NCT05564390

Brief Summary

This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_2

Timeline
36mo left

Started Jun 2024

Longer than P75 for phase_2

Geographic Reach
3 countries

347 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jun 2024May 2029

First Submitted

Initial submission to the registry

September 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 18, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2029

Last Updated

June 11, 2026

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

September 27, 2022

Last Update Submit

June 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

    Will evaluate the feasibility of MATCHBox generating all data needed for assignment to a myeloMATCH clinical trial or determination that no assignment is available, within 72 hours of MDNet receipt of specimens for initial therapy and within 10 days for subsequent therapy. For first treatment assignment and separately for each subsequent treatment assignments: every 50 participants for the first 250 participants and then every 100 participants thereafter, the proportion of participants (cumulative and new participants since prior analysis) with all MDNet data needed to determine a treatment assignment within 72 hours for first assignment and 10 days for subsequent assignments after the MDNet receives specimens will be tallied.

    Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

Secondary Outcomes (9)

  • Time to MDNet generating all data required for treatment substudy or TAP assignment

    Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

  • Time to treatment substudy or TAP assignment

    Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

  • Percent assigned to a myeloMATCH clinical trial

    Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

  • Percent of screened participants who register to a treatment substudy

    Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

  • Assignment to higher tier treatment substudies within myeloMATCH

    Within 72 hours of MDNet receipt of specimens for initial therapy or within 10 days for subsequent therapy

  • +4 more secondary outcomes

Study Arms (39)

MM1MDS-A01 Regimen 1 (ASTX727)

ACTIVE COMPARATOR

Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR, CRL, or CRh at the end of cycle 6 may cross-over to Regimen 2. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and Cedazuridine

MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)

EXPERIMENTAL

Patients receive ASTX727 PO QD on days 1-5 and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience CR, PR, or SD any time after 4 cycles of treatment may be reassessed in order to go to a higher myeloMATCH tier assignment or to TAP. Patients also undergo bone marrow biopsy and aspiration throughout the study. Patients may also undergo optional buccal swab on study, and/or optional additional bone marrow aspiration and blood sample collection on study and at disease progression.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and CedazuridineDrug: Enasidenib

MM1MDS-CTG02 Arm 1 (Luspatercept)

EXPERIMENTAL

Patients receive luspatercept SC on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationBiological: Luspatercept

MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)

EXPERIMENTAL

Patients receive luspatercept SC on day 1 and epoetin alfa SC QW for each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationBiological: Epoetin AlfaBiological: Luspatercept

MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)

EXPERIMENTAL

Patients receive luspatercept SC on day 1 and emavusertib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationBiological: EmavusertibBiological: Luspatercept

MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)

EXPERIMENTAL

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

Drug: AzacitidineProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionDrug: Venetoclax

MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)

EXPERIMENTAL

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

Drug: AzacitidineProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionDrug: GilteritinibDrug: Venetoclax

MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)

EXPERIMENTAL

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until patient achieves remission, whichever comes first, in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

Drug: AzacitidineProcedure: Biopsy ProcedureProcedure: Biospecimen CollectionDrug: GilteritinibDrug: Venetoclax

MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)

ACTIVE COMPARATOR

Patients receive ASTX727 PO QD on days 1-5 of each cycle and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR, CRh, or CRi after cycle 4 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and CedazuridineDrug: Venetoclax

MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)

EXPERIMENTAL

Patients receive ASTX727 PO QD on days 1-5 of each cycle, venetoclax PO QD on days 1-28 of each cycle, and olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR, CRh, or CRi after cycle 4 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and CedazuridineDrug: OlutasidenibDrug: Venetoclax

MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)

EXPERIMENTAL

Patients receive ASTX727 PO QD on days 1-5 of each cycle and olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and CedazuridineDrug: Olutasidenib

MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)

ACTIVE COMPARATOR

Patients receive ASTX727 PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients without CR after cycle 6 may then cross-over to Arm 3. Patients with CR, as well as patients without CR but deriving clinical benefit after cycle 6 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and Cedazuridine

MM1OA-MDS-A05 Cohort C (olutasidenib)

EXPERIMENTAL

Patients receive olutasidenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit after cycle 6 continue treatment cycles every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Olutasidenib

MM1OA-S03 Arm 1 (ASTX727, venetoclax)

ACTIVE COMPARATOR

Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and CedazuridineDrug: Venetoclax

MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)

EXPERIMENTAL

Patients receive ASTX727 PO QD on days 1-5, venetoclax PO QD on days 1-28, and enasidenib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone marrow aspiration, and bone marrow biopsy throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: Decitabine and CedazuridineDrug: EnasidenibDrug: Venetoclax

MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)

ACTIVE COMPARATOR

Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: Decitabine and CedazuridineDrug: Venetoclax

MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)

EXPERIMENTAL

Patients receive ASTX727 PO QD on days 1-5 and venetoclax PO QD on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: Decitabine and CedazuridineDrug: Venetoclax

MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)

ACTIVE COMPARATOR

Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.

Other: Best PracticeProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: CytarabineDrug: Daunorubicin HydrochlorideProcedure: Echocardiography TestDrug: Gemtuzumab OzogamicinProcedure: Multigated Acquisition Scan

MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)

EXPERIMENTAL

Patients receive gemtuzumab ozogamicin IV on days 1 and 4, cytarabine IV, continuously, on days 1-7 and daunorubicin IV on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care consolidation/post-remission treatment at the discretion of the treating physician. Patients undergo echocardiography or MUGA scan during screening and bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients may also undergo optional buccal swab collection throughout the study.

Other: Best PracticeProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyDrug: CytarabineDrug: Daunorubicin HydrochlorideProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)

EXPERIMENTAL

Patients receive daunorubicin IV on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax PO QD on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: CytarabineDrug: Daunorubicin HydrochlorideDrug: Venetoclax

MM1YA-CTG01 Arm II (azacitidine, venetoclax)

EXPERIMENTAL

Patients receive azacitidine IV or SC on days 1-7 or days 1-5 and 8-9 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.

Drug: AzacitidineProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: Venetoclax

MM1YA-CTG01 Arm III (daunorubicin, cytarabine)

ACTIVE COMPARATOR

Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: CytarabineDrug: Daunorubicin Hydrochloride

MM1YA-S01 Arm I (cytarabine, daunorubicin)

ACTIVE COMPARATOR

Patients receive cytarabine IV continuously on days 1-7 and daunorubicin IV on days 1-3 per standard approach of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 1-5 and daunorubicin IV on days 1-2. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: CytarabineDrug: Daunorubicin HydrochlorideProcedure: Echocardiography TestProcedure: Multigated Acquisition Scan

MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)

EXPERIMENTAL

Patients receive cytarabine IV continuously on days 2-8 and daunorubicin IV on days 2-4 with venetoclax PO on days 1-11 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of cytarabine IV continuously on days 2-6 and daunorubicin IV on days 2-3 with venetoclax PO on days 1-8. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationDrug: CytarabineDrug: Daunorubicin HydrochlorideProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM1YA-S01 Arm III (azacitidine, venetoclax)

EXPERIMENTAL

Patients receive azacitidine SC or IV on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

Drug: AzacitidineProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM1YA-S01 Arm IV (Vyxeos)

EXPERIMENTAL

Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Echocardiography TestDrug: Liposome-encapsulated Daunorubicin-CytarabineProcedure: Multigated Acquisition Scan

MM1YA-S01 Arm V (Vyxeos, venetoclax)

EXPERIMENTAL

Patients receive daunorubicin and cytarabine liposome IV over 90 minutes on days 1, 3, and 5 and venetoclax PO on days 1-14 of each cycle. Cycles repeat every 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity. Patients may receive an additional cycle of daunorubicin and cytarabine liposome IV over 90 minutes on days 1 and 3 and venetoclax PO on days 1-7. Patients undergo ECHO or MUGA scan during screening. Patients also undergo a bone marrow aspiration and collection of blood throughout the trial.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Echocardiography TestDrug: Liposome-encapsulated Daunorubicin-CytarabineProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM2YA-EA01 Arm A (cytarabine)

ACTIVE COMPARATOR

Patients receive cytarabine IV on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

Procedure: Biopsy ProcedureDrug: CytarabineProcedure: Echocardiography TestProcedure: Multigated Acquisition Scan

MM2YA-EA01 Arm B (cytarabine, venetoclax)

EXPERIMENTAL

Patients receive cytarabine IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

Procedure: Biopsy ProcedureDrug: CytarabineProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM2YA-EA01 Arm C (Vyxeos, venetoclax)

EXPERIMENTAL

Patients receive Vyxeos IV and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

Procedure: Biopsy ProcedureProcedure: Echocardiography TestDrug: Liposome-encapsulated Daunorubicin-CytarabineProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM2YA-EA01 Arm D (azacitidine, venetoclax)

EXPERIMENTAL

Patients receive azacitidine IV or SC and venetoclax PO on study. Patients undergo bone marrow aspiration and biopsy on study. Patients may also undergo ECHO and/or MUGA as clinically indicated.

Drug: AzacitidineProcedure: Biopsy ProcedureProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Venetoclax

MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)

EXPERIMENTAL

Patients receive venetoclax PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.

Procedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyDrug: BusulfanProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FludarabineDrug: MelphalanProcedure: Multigated Acquisition ScanProcedure: Positron Emission TomographyDrug: Venetoclax

MM3TCT-A03 Conditioning 1B (matched donors with placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD on days -10 to -2, fludarabine IV on days -6 or -5 to -2 and busulfan IV on days -3 to -2 or BID on days -5 to -2 or melphalan IV on day -2. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.

Procedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyDrug: BusulfanProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FludarabineDrug: MelphalanProcedure: Multigated Acquisition ScanDrug: Placebo AdministrationProcedure: Positron Emission Tomography

MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)

EXPERIMENTAL

Patients receive venetoclax PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.

Procedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FludarabineDrug: MelphalanProcedure: Multigated Acquisition ScanProcedure: Positron Emission TomographyRadiation: Total-Body IrradiationDrug: Venetoclax

MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD on days -10 to -2, melphalan IV on day -6, fludarabine IV on days -5 to -2 and undergo total body irradiation once on day -1. Patients then receive hematopoietic cell transplant IV on day 0. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray, echocardiography or MUGA during screening, and bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.

Procedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Echocardiography TestDrug: FludarabineDrug: MelphalanDrug: Placebo AdministrationProcedure: Positron Emission TomographyRadiation: Total-Body Irradiation

MM3TCT-A03 Maintenance I (venetoclax)

EXPERIMENTAL

Patients receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Multigated Acquisition ScanProcedure: Positron Emission TomographyDrug: Venetoclax

MM3TCT-A03 Maintenance II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 1 year post transplant (9 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and blood, urine and buccal swab collection throughout the study. Patients may also undergo PET scan and/or CT scan throughout the study.

Procedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Computed TomographyDrug: Placebo AdministrationProcedure: Positron Emission Tomography

Screening (mutation carrier screening)

EXPERIMENTAL

Patients undergo bone marrow aspiration and collection of blood on study. Patients' bone marrow and blood specimens undergo rapid genetic testing. Patients are then assigned to a specific substudy containing a therapy targeted to the patient's mutational profile. If there is no targetable mutation, the patient is placed on a substudy testing novel combinations that do not contain a target-specific drug. Patients who are not eligible for any MYELOMATCH substudy are assigned to TAP.

Procedure: Mutation Carrier Screening

TAP (SOC treatment, mutation carrier screening)

EXPERIMENTAL

Patients continue SOC treatment and undergo continued bone marrow aspiration and blood collection for possible future substudy assignment.

Other: Best PracticeProcedure: Mutation Carrier Screening

Interventions

Given IV or SC

Also known as: 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)MM1YA-CTG01 Arm II (azacitidine, venetoclax)MM1YA-S01 Arm III (azacitidine, venetoclax)MM2YA-EA01 Arm D (azacitidine, venetoclax)

Given PO

Also known as: ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)MM1OA-S03 Arm 1 (ASTX727, venetoclax)MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)MM1YA-CTG01 Arm II (azacitidine, venetoclax)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)MM1YA-S01 Arm III (azacitidine, venetoclax)MM1YA-S01 Arm V (Vyxeos, venetoclax)MM2YA-EA01 Arm B (cytarabine, venetoclax)MM2YA-EA01 Arm C (Vyxeos, venetoclax)MM2YA-EA01 Arm D (azacitidine, venetoclax)MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Maintenance I (venetoclax)

Given PO

MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)MM3TCT-A03 Maintenance II (placebo)

Given IV

Also known as: Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)

Given PO

Also known as: ASP 2215, ASP-2215, ASP2215
MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)

Receive SOC treatment

Also known as: standard of care, standard therapy
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)TAP (SOC treatment, mutation carrier screening)

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx
MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)MM2YA-EA01 Arm A (cytarabine)MM2YA-EA01 Arm B (cytarabine, venetoclax)MM2YA-EA01 Arm C (Vyxeos, venetoclax)MM2YA-EA01 Arm D (azacitidine, venetoclax)

Undergo collection of blood, urine, and/or buccal swab samples

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
MM1MDS-A01 Regimen 1 (ASTX727)MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)MM1MDS-CTG02 Arm 1 (Luspatercept)MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)MM1OA-EA02 Regimen 1 (azacitidine, venetoclax)MM1OA-EA02 Regimen 2 (azacitidine, venetoclax, gilteritinib)MM1OA-EA02 Regimen 3 (azacitidine, venetoclax, gilteritinib)MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)MM1OA-MDS-A05 Cohort C (olutasidenib)MM1OA-S03 Arm 1 (ASTX727, venetoclax)MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)MM1YA-CTG01 Arm II (azacitidine, venetoclax)MM1YA-CTG01 Arm III (daunorubicin, cytarabine)MM1YA-S01 Arm I (cytarabine, daunorubicin)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)MM1YA-S01 Arm III (azacitidine, venetoclax)MM1YA-S01 Arm IV (Vyxeos)MM1YA-S01 Arm V (Vyxeos, venetoclax)MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)MM3TCT-A03 Maintenance I (venetoclax)MM3TCT-A03 Maintenance II (placebo)

Undergo bone marrow aspiration

MM1MDS-A01 Regimen 1 (ASTX727)MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)MM1MDS-CTG02 Arm 1 (Luspatercept)MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)MM1OA-MDS-A05 Cohort C (olutasidenib)MM1OA-S03 Arm 1 (ASTX727, venetoclax)MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)MM1YA-CTG01 Arm II (azacitidine, venetoclax)MM1YA-CTG01 Arm III (daunorubicin, cytarabine)MM1YA-S01 Arm I (cytarabine, daunorubicin)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)MM1YA-S01 Arm III (azacitidine, venetoclax)MM1YA-S01 Arm IV (Vyxeos)MM1YA-S01 Arm V (Vyxeos, venetoclax)

Given IV

Also known as: 1, 4-Bis[methanesulfonoxy]butane, BUS, Busilvex, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)

Undergo chest x-ray

Also known as: Chest X-ray
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)

Undergo ECHO

Also known as: EC, Echocardiography
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-S01 Arm I (cytarabine, daunorubicin)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)MM1YA-S01 Arm III (azacitidine, venetoclax)MM1YA-S01 Arm IV (Vyxeos)MM1YA-S01 Arm V (Vyxeos, venetoclax)MM2YA-EA01 Arm A (cytarabine)MM2YA-EA01 Arm B (cytarabine, venetoclax)MM2YA-EA01 Arm C (Vyxeos, venetoclax)MM2YA-EA01 Arm D (azacitidine, venetoclax)MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)

Given PO

Also known as: AG 221, AG-221, AG221, CC-90007 Free Base
MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)
Epoetin AlfaBIOLOGICAL

Given SC

Also known as: EPO, Epoetin alfa-epbx, Epogen, Eprex, Procrit, Retacrit
MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)
LuspaterceptBIOLOGICAL

Given SC

Also known as: ACE 536, ACE-536, ACE536, Luspatercept-aamt, Reblozyl
MM1MDS-CTG02 Arm 1 (Luspatercept)MM1MDS-CTG02 Arm 2 (Luspatercept with epoetin alfa)MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-S01 Arm I (cytarabine, daunorubicin)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)MM1YA-S01 Arm III (azacitidine, venetoclax)MM1YA-S01 Arm IV (Vyxeos)MM1YA-S01 Arm V (Vyxeos, venetoclax)MM2YA-EA01 Arm A (cytarabine)MM2YA-EA01 Arm B (cytarabine, venetoclax)MM2YA-EA01 Arm C (Vyxeos, venetoclax)MM2YA-EA01 Arm D (azacitidine, venetoclax)MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Maintenance I (venetoclax)

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)MM3TCT-A03 Maintenance I (venetoclax)MM3TCT-A03 Maintenance II (placebo)

Given

Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)MM1YA-CTG01 Arm III (daunorubicin, cytarabine)MM1YA-S01 Arm I (cytarabine, daunorubicin)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)MM2YA-EA01 Arm A (cytarabine)MM2YA-EA01 Arm B (cytarabine, venetoclax)

Given IV

Also known as: Fluradosa
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)

Given IV

Also known as: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)

Given IV

Also known as: Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem
MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM1YA-CTG01 Arm I (daunorubicin, cytarabine, venetoclax)MM1YA-CTG01 Arm III (daunorubicin, cytarabine)MM1YA-S01 Arm I (cytarabine, daunorubicin)MM1YA-S01 Arm II (cytarabine, daunorubicin, venetoclax)

Given PO

Also known as: ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi
MM1MDS-A01 Regimen 1 (ASTX727)MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)MM1OA-S03 Arm 1 (ASTX727, venetoclax)MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)MM1OA-S04 Arm 1 (ASTX727 with standard duration venetoclax)MM1OA-S04 Arm 2 (ASTX727 with shorter duration venetoclax)

Given IV

Also known as: Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalan for Injection-Hepatic Delivery System, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)
EmavusertibBIOLOGICAL

Given PO

Also known as: AU 4948, AU-4948, CA 4948, CA-4948, CA4948, Interleukin-1 Receptor-associated Kinase 4 Inhibitor CA-4948, IRAK4 Inhibitor CA-4948
MM1MDS-CTG02 Arm 3 (Luspatercept and emavusertib)

Undergo rapid genetic testing

Screening (mutation carrier screening)TAP (SOC treatment, mutation carrier screening)

Given IV

Also known as: CPX 351, CPX-351, CPX351, Cytarabine and Daunorubicin Liposomal, Cytarabine-Daunorubicin Liposome for Injection, Daunorubicin and Cytarabine (Liposomal), Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, Vyxeos
MM1YA-S01 Arm IV (Vyxeos)MM1YA-S01 Arm V (Vyxeos, venetoclax)MM2YA-EA01 Arm C (Vyxeos, venetoclax)

Undergo total body irradiation

Also known as: SCT_TBI, TBI, Total Body Irradiation, Whole Body, Whole Body Irradiation, Whole-Body Irradiation
MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)

Given PO

Also known as: FT 2102, FT-2102, FT2102, IDH1-R132 Inhibitor FT-2102, Rezlidhia
MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)MM1OA-MDS-A05 Cohort C (olutasidenib)

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)MM3TCT-A03 Maintenance I (venetoclax)MM3TCT-A03 Maintenance II (placebo)

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow
MM1MDS-A01 Regimen 1 (ASTX727)MM1MDS-A01 Regimen 2 (ASTX727, enasidenib)MM1OA-MDS-A05 Cohort A, Arm 1 (ASTX727, venetoclax)MM1OA-MDS-A05 Cohort A,Arm 2 (ASTX727,venetoclax,olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 3 (ASTX727, olutasidenib)MM1OA-MDS-A05 Cohort B, Arm 4 (ASTX727)MM1OA-MDS-A05 Cohort C (olutasidenib)MM1OA-S03 Arm 1 (ASTX727, venetoclax)MM1OA-S03 Arm 2 (ASTX727, venetoclax, enasidenib)MM1YA-A04 Regimen 1 (gemtuzumab ozogamicin, chemotherapy)MM1YA-A04 Regimen 2 (venetoclax, chemotherapy)MM3TCT-A03 Conditioning 1A (matched donors with venetoclax)MM3TCT-A03 Conditioning 1B (matched donors with placebo)MM3TCT-A03 Conditioning 2A (haplo/mismatch with venetoclax)MM3TCT-A03 Conditioning 2B (haplo/mismatch with placebo)MM3TCT-A03 Maintenance I (venetoclax)MM3TCT-A03 Maintenance II (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.
  • Participants must be \>= 18 years of age.
  • Participants must not have received prior anti-cancer therapy for AML or MDS.
  • Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.
  • Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction.
  • Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.
  • Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.
  • Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy
  • Note: active hormonal therapy is allowed
  • Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.
  • Participants must agree to have translational medicine specimens submitted.
  • Participants must be offered the opportunity to participate in specimen banking.
  • Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.
  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
  • Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (347)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

SUSPENDED

Kaiser Permanente Dublin

Dublin, California, 94568, United States

RECRUITING

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

RECRUITING

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, 93720, United States

RECRUITING

Kaiser Permanente-Fresno

Fresno, California, 93720, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

Tibor Rubin VA Medical Center

Long Beach, California, 90822, United States

ACTIVE NOT RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Kaiser Permanente- Modesto MOB II

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

RECRUITING

Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

RECRUITING

UCSF Medical Center-Parnassus

San Francisco, California, 94143, United States

RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

RECRUITING

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

RECRUITING

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

RECRUITING

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, 06516, United States

RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

Memorial Hospital West

Pembroke Pines, Florida, 33028, United States

RECRUITING

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

RECRUITING

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

RECRUITING

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

RECRUITING

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864, United States

RECRUITING

Advocate Outpatient Center - Aurora

Aurora, Illinois, 60506, United States

RECRUITING

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

RECRUITING

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

RECRUITING

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, 61021, United States

RECRUITING

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

RECRUITING

Advocate Sherman Hospital

Elgin, Illinois, 60123, United States

RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

RECRUITING

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

RECRUITING

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States

RECRUITING

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

RECRUITING

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

RECRUITING

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States

RECRUITING

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States

RECRUITING

Edward Hines Jr VA Hospital

Hines, Illinois, 60141, United States

RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

RECRUITING

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States

RECRUITING

Condell Memorial Hospital

Libertyville, Illinois, 60048, United States

RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699, United States

RECRUITING

Advocate Outpatient Center - Oak Lawn

Oak Lawn, Illinois, 60453, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

RECRUITING

Advocate High Tech Medical Park

Palos Heights, Illinois, 60463, United States

RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

RECRUITING

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, 61571, United States

RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

UI Healthcare Mission Cancer and Blood - Pella

Pella, Iowa, 50219, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

The Iowa Clinic PC

West Des Moines, Iowa, 50266, United States

RECRUITING

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

RECRUITING

HaysMed

Hays, Kansas, 67601, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

RECRUITING

Salina Regional Health Center

Salina, Kansas, 67401, United States

RECRUITING

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, 66606, United States

SUSPENDED

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States

RECRUITING

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, 70805, United States

RECRUITING

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Our Lady of The Lake

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MaineHealth Cancer Care and IV Therapy - Brunswick

Brunswick, Maine, 04011, United States

RECRUITING

Mid Coast Hospital

Brunswick, Maine, 04011, United States

RECRUITING

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States

RECRUITING

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States

RECRUITING

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

RECRUITING

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

SUSPENDED

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

RECRUITING

Hurley Medical Center

Flint, Michigan, 48503, United States

RECRUITING

Allegiance Health

Jackson, Michigan, 49201, United States

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

RECRUITING

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

Regions Hospital

Saint Paul, Minnesota, 55101, United States

RECRUITING

United Hospital

Saint Paul, Minnesota, 55102, United States

RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Golden Triangle

Columbus, Mississippi, 39705, United States

RECRUITING

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States

RECRUITING

University Health Truman Medical Center

Kansas City, Missouri, 64108, United States

RECRUITING

University of Kansas Cancer Center - Briarcliff

Kansas City, Missouri, 64116, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Mercy Hospital South

St Louis, Missouri, 63128, United States

SUSPENDED

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States

RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, 59711, United States

RECRUITING

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

RECRUITING

Logan Health Medical Center

Kalispell, Montana, 59901, United States

RECRUITING

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States

RECRUITING

Community Medical Center

Missoula, Montana, 59804, United States

RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102, United States

RECRUITING

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89183, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

RECRUITING

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

RECRUITING

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States

RECRUITING

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, 07450, United States

RECRUITING

Community Medical Center

Toms River, New Jersey, 08755, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

SUSPENDED

North Shore University Hospital

Manhasset, New York, 11030, United States

SUSPENDED

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Rochester General Hospital

Rochester, New York, 14621, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

RECRUITING

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914, United States

RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

SUSPENDED

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

RECRUITING

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

RECRUITING

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Reading Hospital

West Reading, Pennsylvania, 19611, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

RECRUITING

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

RECRUITING

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Collierville

Collierville, Tennessee, 38017, United States

RECRUITING

University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States

RECRUITING

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

George E Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States

RECRUITING

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

RECRUITING

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States

RECRUITING

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

RECRUITING

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110, United States

RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

RECRUITING

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States

RECRUITING

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

RECRUITING

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

RECRUITING

Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, 53548, United States

RECRUITING

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

RECRUITING

William S Middleton VA Medical Center

Madison, Wisconsin, 53705, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States

RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051, United States

RECRUITING

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States

RECRUITING

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

RECRUITING

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, 53151, United States

RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154, United States

RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

RECRUITING

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

RECRUITING

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States

RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081, United States

RECRUITING

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

RECRUITING

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States

RECRUITING

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

RECRUITING

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

RECRUITING

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188, United States

RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

RECRUITING

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

RECRUITING

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095, United States

RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

RECRUITING

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

QEII Health Sciences Centre/Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CSSS Champlain-Charles Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

CIUSSSEMTL-Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

RECRUITING

San Juan City Hospital

San Juan, 00936, Puerto Rico

RECRUITING

Related Publications (1)

  • Tiong IS, Loo S. Targeting Measurable Residual Disease (MRD) in Acute Myeloid Leukemia (AML): Moving beyond Prognostication. Int J Mol Sci. 2023 Mar 1;24(5):4790. doi: 10.3390/ijms24054790.

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyeloproliferative DisordersMyelodysplastic Syndromes

Interventions

Stem Cell TransplantationAzacitidinePractice Guidelines as TopicStandard of CareBiopsySpecimen HandlingBusulfanX-RaysCytarabineDaunorubicindecitabine and cedazuridine drug combinationCA-4948enasidenibEpoetin AlfafludarabineGemtuzumabgilteritinibCPX-351InjectionsLiposomesluspaterceptMelphalanolutasidenibMagnetic Resonance SpectroscopyWhole-Body Irradiationvenetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesGuidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health CareCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, SurgicalInvestigative TechniquesButylene GlycolsGlycolsAlcoholsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingArabinonucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCalicheamicinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsDrug Administration RoutesDrug TherapyMembranes, ArtificialBiomedical and Dental MaterialsDrug CarriersDosage FormsPharmaceutical PreparationsManufactured MaterialsTechnology, Industry, and AgricultureBiomimetic MaterialsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsSpectrum AnalysisChemistry Techniques, AnalyticalRadiotherapy

Study Officials

  • Jerald P Radich

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 3, 2022

Study Start

June 18, 2024

Primary Completion (Estimated)

May 15, 2029

Study Completion (Estimated)

May 15, 2029

Last Updated

June 11, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

More information

Locations