Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

NCT04530565 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: NCI-2020-06381EA9181U10CA180820
• Study Type: interventional
• Target: 348
• Locations: 3 countries
• Sites: 211

Brief Summary

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

Conditions

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Will compare OS following induction with steroids + tyrosine kinase inhibitor (TKI) + blinatumomab and induction with steroids + TKI + chemotherapy. Will be based on an intent-to-treat analysis. Estimates of OS including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparisons of OS between treatment arms will be conducted using the one-sided stratified log-rank test with steroid responsiveness, type of TKI intended to receive and age at diagnosis, the same factors used in randomization, as stratification factors. Cox proportional hazards models of OS, stratified on the same factors used in the randomization, will be used to assess the effect of treatment by adjusting other possible clinical and biological risk factors, including cytogenetic abnormalities.

  Time between randomization and death from any cause, assessed up to 10 years from the date of registration

Secondary Outcomes (4)

• Rate of minimal residual disease (MRD) negativity

  At week 15

• Event free survival (EFS)

  Time from randomization to failure to achieve induction molecular remission by week 15, confirmed molecular relapse after molecular remission or to death in remission, assessed up to 10 years from the date of registration

• Rate of MRD negativity

  After re-induction

• Incidence of adverse events

  Up to 10 years from the date of registration

Study Arms (5)

Arm A (steroid, TKI), Single Arm Pre-Induction

ACTIVE COMPARATOR

Patients receive prednisone PO QD on days 1-21 and ponatinib PO QD or dasatinib PO QD on days 1-21 based on investigator's choice.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Dasatinib; Procedure: Echocardiography Test; Procedure: Electrocardiography; Procedure: Lumbar Puncture; Procedure: Multigated Acquisition Scan; Drug: Ponatinib Hydrochloride; Drug: Prednisone

Arm B (steroid, TKI, chemotherapy)

EXPERIMENTAL

See Detailed Description.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dasatinib; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Procedure: Electrocardiography; Procedure: Lumbar Puncture; Drug: Mesna; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Ponatinib Hydrochloride; Drug: Vincristine Sulfate

Arm C (steroid, TKI, chemotherapy, immunotherapy)

EXPERIMENTAL

CYCLE 1: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28, followed by methotrexate IT on day 29 or 30. CYCLE 2: Patients receive ponatinib PO QD or dasatinib PO QD on days 1-28. Patients also receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Dasatinib; Drug: Dexamethasone; Procedure: Echocardiography Test; Procedure: Electrocardiography; Procedure: Lumbar Puncture; Drug: Mesna; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Ponatinib Hydrochloride

Arm D (steroid, TKI, chemotherapy, immunotherapy)

EXPERIMENTAL

Patients treated on Arm B who remain MRD positive at the end of induction therapy receive blinatumomab based re-induction identical to the regimen described for Arm C. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.

Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cyclophosphamide; Drug: Dasatinib; Drug: Dexamethasone; Procedure: Echocardiography Test; Procedure: Electrocardiography; Procedure: Lumbar Puncture; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Ponatinib Hydrochloride

Arm E (steroid, TKI, chemotherapy)

EXPERIMENTAL

Patients treated on Arm C who remain MRD positive at the end of induction therapy receive chemotherapy based re-induction which is identical to regimen described for Arm B according to patient's age and the pre-specified chemotherapy arm. Patients whose molecular test remains MRD positive after re-induction proceed to follow-up at the discretion of the investigator or receive anti CD-19 CAR- T cell therapy, inotuzumab ozogamicin, intensive chemotherapy, or palliative care.

Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration and Biopsy; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Dasatinib; Drug: Dexamethasone; Drug: Doxorubicin Hydrochloride; Procedure: Echocardiography Test; Procedure: Electrocardiography; Procedure: Lumbar Puncture; Drug: Methotrexate; Procedure: Multigated Acquisition Scan; Drug: Ponatinib Hydrochloride; Drug: Vincristine Sulfate

Interventions

Blinatumomab BIOLOGICAL

Given IV

Also known as: AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI 538, MEDI-538, MEDI538, MT 103, MT-103, MT103

Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy)

Bone Marrow Aspiration and Biopsy PROCEDURE

Undergo bone marrow aspiration and biopsy

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719

Arm B (steroid, TKI, chemotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Cytarabine DRUG

Given IV or IT

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

Arm B (steroid, TKI, chemotherapy); Arm E (steroid, TKI, chemotherapy)

Dasatinib DRUG

Given PO

Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Dexamethasone DRUG

Given PO or IV

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, LenaDex, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Echocardiography Test PROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Electrocardiography PROCEDURE

Undergo ECG

Also known as: ECG, EKG

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Lumbar Puncture PROCEDURE

Undergo lumbar puncture

Also known as: LP, Spinal Tap

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Mesna DRUG

Given IV

Also known as: 2-Mercaptoethanesulfonate, Sodium Salt, Ausobronc, D-7093, Filesna, Mercaptoethane Sulfonate, Mercaptoethanesulfonate, Mesnex, Mesnil, Mesnum, Mexan, Mistabron, Mistabronco, Mitexan, Mucofluid, Mucolene, UCB 3983, Uromitexan, Ziken

Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy)

Methotrexate DRUG

Given IV or IT

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, MUGA, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Ponatinib Hydrochloride DRUG

Given PO

Also known as: AP24534 HCl, Iclusig

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Arm A (steroid, TKI), Single Arm Pre-Induction

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Arm B (steroid, TKI, chemotherapy); Arm E (steroid, TKI, chemotherapy)

Doxorubicin Hydrochloride DRUG

Given IV

Also known as: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, FI106, hydroxydaunorubicin, Rubex

Arm B (steroid, TKI, chemotherapy); Arm E (steroid, TKI, chemotherapy)

Biospecimen Collection PROCEDURE

Correlative studies

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm A (steroid, TKI), Single Arm Pre-Induction; Arm B (steroid, TKI, chemotherapy); Arm C (steroid, TKI, chemotherapy, immunotherapy); Arm D (steroid, TKI, chemotherapy, immunotherapy); Arm E (steroid, TKI, chemotherapy)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0)
• Patient must be \>= 18 and =\< 75 years of age
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3
• Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL)
• Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation
• NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (\> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation
• Patient must not have a diagnosis of BCR/ABL T-ALL
• Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible
• Patient must not have unstable epilepsy that requires treatment
• Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible
• ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1
• Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center
• Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any woman, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of step 1 registration, while on study treatment, and until at least six months after the last dose of study treatment
• Total bilirubin =\< 3 mg/dL (patients with Gilbert's syndrome must have a total bilirubin =\< 5 mg/dL) (obtained =\< 28 days prior to step 1 registration)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (211)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508, United States

Location

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508, United States

Location

Alaska Women's Cancer Care

Anchorage, Alaska, 99508, United States

Location

Anchorage Oncology Centre

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

Community Cancer Institute

Clovis, California, 93611, United States

Location

University Oncology Associates

Clovis, California, 93611, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, 96817, United States

Location

Kuakini Medical Center

Honolulu, Hawaii, 96817, United States

Location

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, 96766, United States

Location

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, 96701, United States

Location

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

Location

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

Location

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

Location

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States

Location

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois, 60527, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

Loyola Medicine Homer Glen

Homer Glen, Illinois, 60491, United States

Location

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, 60160, United States

Location

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Mary Greeley Medical Center

Ames, Iowa, 50010, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

Location

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

Location

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

Location

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

Location

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846, United States

Location

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245, United States

Location

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States

Location

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

Location

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States

Location

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States

Location

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

Location

Chelsea Hospital

Chelsea, Michigan, 48118, United States

Location

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States

Location

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346, United States

Location

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346, United States

Location

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Cancer Hematology Centers - Flint

Flint, Michigan, 48503, United States

Location

Genesee Hematology Oncology PC

Flint, Michigan, 48503, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044, United States

Location

Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States

Location

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341, United States

Location

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

Location

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States

Location

Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, 48315, United States

Location

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661, United States

Location

Henry Ford Wyandotte Hospital

Wyandotte, Michigan, 48192, United States

Location

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

Location

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

Location

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, 63011, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Mercy Hospital South

St Louis, Missouri, 63128, United States

Location

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

Location

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Mercy Hospital Washington

Washington, Missouri, 63090, United States

Location

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Saint Charles Health System

Bend, Oregon, 97701, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015, United States

Location

Bay Area Hospital

Coos Bay, Oregon, 97420, United States

Location

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Saint Charles Health System-Redmond

Redmond, Oregon, 97756, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Vanderbilt-Ingram Cancer Center Cool Springs

Franklin, Tennessee, 37067, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520, United States

Location

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531, United States

Location

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503, United States

Location

PeaceHealth Saint John Medical Center

Longview, Washington, 98632, United States

Location

Pacific Gynecology Specialists

Seattle, Washington, 98104, United States

Location

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107, United States

Location

Swedish Medical Center-Cherry Hill

Seattle, Washington, 98122-5711, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

Location

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284, United States

Location

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362, United States

Location

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States

Location

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

Location

San Juan City Hospital

San Juan, 00936, Puerto Rico

Location

Related Publications (1)

• Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.

  PMID: 41671463 DERIVED

MeSH Terms

Interventions

Specimen Handling; blinatumomab; N,N-dicyclohexyl-isoborneol-10-sulfonamide; Biopsy; Cyclophosphamide; Cytarabine; Dasatinib; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate; Doxorubicin; Spinal Puncture; Mesna; Methotrexate; merphos; ponatinib; Prednisone; deltacortene; prednylidene; Vincristine

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Thiazoles; Sulfur Compounds; Azoles; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Yishai Ofran

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: August 28, 2020
• Study Start: January 25, 2021
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IL (2); US (207); PR (2)