A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

NCT04293562 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: AAML1831NCI-2020-00546U10CA180886
• Study Type: interventional
• Target: 1,186
• Locations: 4 countries
• Sites: 205

Brief Summary

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death.

  Up to 3 years

Secondary Outcomes (7)

• Overall survival (OS)

  Up to 3 years

• Proportion of patients positive for minimal residual disease (MRD+)

  Up to 4 weeks

• Proportion of patients who died during protocol therapy

  Up to 2 years

• Incidence of adverse events

  Up to 2 years

• Relapse rate

  Up to 3 years

Other Outcomes (3)

• Course duration

  Up to 2 years

• Length of hospitalization

  Up to 2 years

• Time to count recovery

  Up to 2 years

Study Arms (14)

Arm A High Risk Group

EXPERIMENTAL

Arm A High Risk Group: See Detailed Description.

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm A Low Risk Group 1

EXPERIMENTAL

Arm A Low Risk Group 1: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm A Low Risk Group 2

EXPERIMENTAL

Arm A Low Risk Group 2: See Detailed Description.

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm AC High Risk Group

EXPERIMENTAL

Arm AC High Risk Group: See Detailed Description.

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm AC Low Risk Group 2

EXPERIMENTAL

Arm AC Low Risk Group 2: See Detailed Description.

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm AD High Risk Group

EXPERIMENTAL

Arm AD High Risk Group: See Detailed Description.

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm AD Low Risk Group 2

EXPERIMENTAL

Arm AD Low Risk Group 2: See Detailed Description.

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm B High Risk Group

EXPERIMENTAL

Arm B High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm B Low Risk Group 1

EXPERIMENTAL

Arm B Low Risk Group 1: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm B Low Risk Group 2

EXPERIMENTAL

Arm B Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm BC High Risk Group

EXPERIMENTAL

Arm BC High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm BC Low Risk Group 2

EXPERIMENTAL

Arm BC Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm BD High Risk Group

EXPERIMENTAL

Arm BD High Risk Group: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Arm BD Low Risk Group 2

EXPERIMENTAL

Arm BD Low Risk Group 2: See Detailed Description. (CLOSED TO ACCRUAL 11/19/2024)

Drug: Asparaginase Erwinia chrysanthemi; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Drug: Cytarabine; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Other: Fludeoxyglucose F-18; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Procedure: Magnetic Resonance Imaging; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Therapeutic Hydrocortisone

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

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

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Bone Marrow Aspiration PROCEDURE

Undergo BM aspiration

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Computed Tomography PROCEDURE

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

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

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 A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Daunorubicin Hydrochloride DRUG

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

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2

Dexrazoxane Hydrochloride DRUG

Given IV

Also known as: Cardioxane, Totect, Zinecard

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm BC Low Risk Group 2; Arm BD Low Risk Group 2

Etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Fludeoxyglucose F-18 OTHER

Undergo FDG-PET

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Gemtuzumab Ozogamicin DRUG

Given IV

Also known as: Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Gilteritinib Fumarate DRUG

Given PO/NG/G-tube

Also known as: ASP-2215 Hemifumarate, ASP2215 Hemifumarate, Gilteritinib Hemifumarate, Xospata

Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Liposome-encapsulated Daunorubicin-Cytarabine DRUG

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

Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Methotrexate DRUG

Given 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 A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Mitoxantrone Hydrochloride DRUG

Given IV

Also known as: CL 232315, DHAD, DHAQ, Dihydroxyanthracenedione Dihydrochloride, Mitoxantrone Dihydrochloride, Mitoxantroni Hydrochloridum, Mitozantrone Hydrochloride, Mitroxone, Neotalem, Novantrone, Onkotrone, Pralifan

Arm A Low Risk Group 2; Arm AC Low Risk Group 2; Arm AD Low Risk Group 2; Arm B Low Risk Group 2; Arm BC Low Risk Group 2; Arm BD Low Risk Group 2

Positron Emission Tomography PROCEDURE

Undergo FDG-PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Questionnaire Administration OTHER

Ancillary studies

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Therapeutic Hydrocortisone DRUG

Given IT

Also known as: Aeroseb-HC, Barseb HC, Barseb-HC, Cetacort, Cort-Dome, Cortef, Cortenema, Cortifan, Cortisol, Cortispray, Cortril, Dermacort, Domolene, Eldecort, Hautosone, Heb-Cort, Hydrocortisone, Hydrocortone, Hytone, Komed-HC, Nutracort, Proctocort, Rectoid

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Allogeneic Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo allogeneic HSCT

Also known as: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic

Arm A High Risk Group; Arm AC High Risk Group; Arm AD High Risk Group; Arm B High Risk Group; Arm BC High Risk Group; Arm BD High Risk Group

Bone Marrow Biopsy PROCEDURE

BM biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Arm A High Risk Group; Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC High Risk Group; Arm AC Low Risk Group 2; Arm AD High Risk Group; Arm AD Low Risk Group 2; Arm B High Risk Group; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC High Risk Group; Arm BC Low Risk Group 2; Arm BD High Risk Group; Arm BD Low Risk Group 2

Asparaginase Erwinia chrysanthemi DRUG

Given IM or IV

Also known as: Asparaginase Erwinia chrysanthemi (Recombinant)-rywn, Asparaginase Erwinia chrysanthemi, Recombinant-rywn, Asparaginase Erwinia chrysanthemi-rywn, Crisantaspase, Crisantaspase Biobetter JZP-458, Crisantaspasum, Enrylaze, Erwinase, Erwinaze, JZP 458, JZP-458, JZP458, PF743, RC-P JZP-458, Recombinant Asparaginase erwinia chrysanthemi JZP-458, Recombinant Crisantaspase JZP-458, Recombinant Erwinia asparaginase JZP-458, Rylaze

Arm A Low Risk Group 1; Arm A Low Risk Group 2; Arm AC Low Risk Group 2; Arm AD Low Risk Group 2; Arm B Low Risk Group 1; Arm B Low Risk Group 2; Arm BC Low Risk Group 2; Arm BD Low Risk Group 2

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
• Patients must be less than 22 years of age at the time of study enrollment
• Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease
• Patient must have 1 of the following:
• \>= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
• In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy
• \< 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
• A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell \[WBC\] count \>= 10,000/uL with \>= 10% blasts or a WBC count of \>= 5,000/uL with \>= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)
• ARM C: Patient must be \>= 2 years of age at the time of Late Callback
• ARM C: Patient must have FLT3/ITD allelic ratio \> 0.1 as reported by Molecular Oncology
• ARM C: Patient does not have any congenital long QT syndrome or congenital heart block
• ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
• ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
• ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
• ARM D: Patient must be \>= 2 years of age at the time of Late Callback

You may not qualify if:

• Fanconi anemia
• Shwachman Diamond syndrome
• Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
• Telomere disorders
• Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy
• Any concurrent malignancy
• Juvenile myelomonocytic leukemia (JMML)
• Philadelphia chromosome positive AML
• Mixed phenotype acute leukemia
• Acute promyelocytic leukemia
• Acute myeloid leukemia arising from myelodysplasia
• Therapy-related myeloid neoplasms
• Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) \< 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) \< 24%. \*Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF \>= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen
• Administration of prior anti-cancer therapy except as outlined below:
• Hydroxyurea

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (205)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

USA Health Strada Patient Care Center

Mobile, Alabama, 36604, United States

RECRUITING

Banner Children's at Desert

Mesa, Arizona, 85202, United States

RECRUITING

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

RECRUITING

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

RECRUITING

Kaiser Permanente Downey Medical Center

Downey, California, 90242, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

RECRUITING

Valley Children's Hospital

Madera, California, 93636, United States

RECRUITING

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

RECRUITING

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States

RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

RECRUITING

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, 80218, United States

RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

ACTIVE NOT RECRUITING

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

RECRUITING

UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States

RECRUITING

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

Palms West Radiation Therapy

Loxahatchee Groves, Florida, 33470, United States

ACTIVE NOT RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

RECRUITING

AdventHealth Orlando

Orlando, Florida, 32803, United States

RECRUITING

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

RECRUITING

Nemours Children's Hospital

Orlando, Florida, 32827, United States

RECRUITING

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

RECRUITING

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

ACTIVE NOT RECRUITING

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States

RECRUITING

Saint Mary's Medical Center

West Palm Beach, Florida, 33407, United States

RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Lurie Children's Hospital-Chicago

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

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453, United States

RECRUITING

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068, United States

RECRUITING

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

Blank Children's Hospital

Des Moines, Iowa, 50309, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

RECRUITING

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

RECRUITING

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, 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

SUSPENDED

Tufts Children's Hospital

Boston, Massachusetts, 02111, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

SUSPENDED

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

RECRUITING

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

ACTIVE NOT RECRUITING

Michigan State University

East Lansing, Michigan, 48823, United States

ACTIVE NOT RECRUITING

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

Corewell Health Children's

Royal Oak, Michigan, 48073, United States

RECRUITING

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

RECRUITING

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

SUSPENDED

University of Missouri Children's Hospital

Columbia, Missouri, 65212, United States

SUSPENDED

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

RECRUITING

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

ACTIVE NOT RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

SUSPENDED

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109, United States

SUSPENDED

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135, United States

RECRUITING

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

RECRUITING

Renown Regional Medical Center

Reno, Nevada, 89502, United States

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

RECRUITING

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

RECRUITING

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

SUSPENDED

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

SUSPENDED

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, 10065, 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

SUSPENDED

New York Medical College

Valhalla, New York, 10595, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, 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

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

RECRUITING

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

RECRUITING

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

RECRUITING

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

RECRUITING

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

RECRUITING

Sanford USD Medical Center - Sioux Falls

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

RECRUITING

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403, United States

RECRUITING

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916, United States

RECRUITING

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

RECRUITING

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

El Paso Children's Hospital

El Paso, Texas, 79905, United States

RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Children's Hospital of San Antonio

San Antonio, Texas, 78207, United States

RECRUITING

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, 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 Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

RECRUITING

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Carilion Children's

Roanoke, Virginia, 24014, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States

RECRUITING

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

RECRUITING

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

RECRUITING

West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

RECRUITING

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

ACTIVE NOT RECRUITING

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

ACTIVE NOT RECRUITING

Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

ACTIVE NOT RECRUITING

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Children's Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3, Canada

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Québec, G1V 4G2, Canada

RECRUITING

University Pediatric Hospital

San Juan, 00926, Puerto Rico

RECRUITING

Related Publications (3)

• Leger KJ, Absalon MJ, Demissei BG, Smith AM, Gerbing RB, Alonzo TA, Narayan HK, Hirsch BA, Pollard JA, Razzouk BI, Getz KD, Aplenc R, Kolb EA, Ky B, Cooper TM. Cardiotoxicity of CPX-351 in children and adolescents with relapsed AML: a Children's Oncology Group report. Front Cardiovasc Med. 2024 Jun 14;11:1347547. doi: 10.3389/fcvm.2024.1347547. eCollection 2024.

  PMID: 38947228 DERIVED

• Leger KJ, Robison N, Narayan HK, Smith AM, Tsega T, Chung J, Daniels A, Chen Z, Englefield V, Demissei BG, Lefebvre B, Morrow G, Dizon I, Gerbing RB, Pabari R, Getz KD, Aplenc R, Pollard JA, Chow EJ, Tang WHW, Border WL, Sachdeva R, Alonzo TA, Kolb EA, Cooper TM, Ky B. Rationale and design of the Children's Oncology Group study AAML1831 integrated cardiac substudies in pediatric acute myeloid leukemia therapy. Front Cardiovasc Med. 2023 Dec 1;10:1286241. doi: 10.3389/fcvm.2023.1286241. eCollection 2023.

  PMID: 38107263 DERIVED

• Andolina JR, Fries C, Boulware R, Vargas A, Fraint E, Barth M, Ambrusko S, Comito M, Monteleone P. Successful Bone Marrow Transplantation With Intensive Post-transplant Intrathecal Chemotherapy for CNS Relapsed AML in 2 Infants. J Pediatr Hematol Oncol. 2022 Jan 1;44(1):e264-e267. doi: 10.1097/MPH.0000000000002151.

  PMID: 33843815 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Stem Cell Transplantation; asparaginase erwinia chrysanthemi recombinant; Asparaginase; Specimen Handling; Biopsy; Cytarabine; Daunorubicin; Dexrazoxane; Razoxane; Etoposide; Fluorodeoxyglucose F18; Gemtuzumab; gilteritinib; CPX-351; Injections; Liposomes; Magnetic Resonance Spectroscopy; Methotrexate; merphos; Mitoxantrone; Hydrocortisone

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Diketopiperazines; Piperazines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Deoxyglucose; Deoxy Sugars; Calicheamicins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials; Spectrum Analysis; Chemistry Techniques, Analytical; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Todd M Cooper

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 3, 2020
• Study Start: July 21, 2020
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

US (185); CA (15); AU (4); PR (1)