Acute Myeloid Leukemia Clinical Trial

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

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.

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Full Description

PRIMARY OBJECTIVE:

I. To compare event-free survival (EFS) in children with de novo acute myeloid leukemia (AML) without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A with daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) (DA-GO) versus Arm B with CPX-351 and GO.

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).

II. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib fumarate (gilteritinib) in combination with DA-GO (Arm AC).

III. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD and BD).

IV. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in patients with FLT3/ITD mutations (Arm AC/Arm BC/Arm AD/Arm BD).

V. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (allelic ratio [AR] > 0.1) without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib versus (vs) CPX-GO-gilteritinib (Arm AC vs Arm BC).

VI. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B).

VII. To compare the changes in echocardiography-derived measures of cardiac function, including left ventricular ejection fraction (EF) and global longitudinal strain (GLS), throughout AML therapy in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.

VIII. Determine if early changes in sensitive echocardiographic measures of cardiac function (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant AML receiving therapy on Arms A or B.

IX. To compare longitudinal acute changes in neuropsychological functioning and neurocognitive late effects between those with central nervous system (CNS) disease and those without CNS disease and between those treated with hematopoietic stem cell transplant (HSCT) and those treated with chemotherapy only for patients on Arms A and B.

X. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving standard induction with dexrazoxane hydrochloride (dexrazoxane) vs. CPX-351 in the context of gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies from that observed in non-FLT3 mutant AML without gilteritinib exposure.

EXPLORATORY OBJECTIVES:

I. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR) FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in combination with DA-GO (Arm AC with AR > 0.4).

II. To estimate the EFS, OS, and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with DA-GO (Arm AC).

III. Compare the changes in high sensitivity troponin and natriuretic peptide elevations throughout AML therapy, as measured at the end of each chemotherapy course, in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B.

IV. Quantify the association of host factors (age, sex, body mass index [BMI], race), treatment exposures (cumulative anthracycline dose, anthracycline arm, hematopoietic stem cell transplant vs. chemotherapy alone), early declines in GLS, and elevations in cardiac biomarkers (cTnT and NT-proBNP) with subsequent LVSD.

V. To describe the rates of CNS disease utilizing an updated strategy for diagnosing and defining CNS disease in pediatric AML.

VI. To describe the rates of CNS relapse (both isolated CNS and combined bone marrow/CNS) when utilizing this updated strategy as well as changing CNS prophylaxis and treatment to include triple intrathecal chemotherapy.

VII. To describe the rate of bone marrow measurable residual disease, detected by multi-dimensional flow cytometry, prior to hematopoietic stem cell transplant (HSCT).

VIII. To describe plasma metabolomics that may impact efficacy, toxicity, and/or pharmacokinetics of allogeneic HSCT.

IX. To estimate the prevalence of non-risk stratifying cytogenetic/molecular variants and assess their impact on outcome in childhood AML.

X. To describe the pharmacokinetic parameters of plasma cytarabine and daunorubicin after CPX-351 administration to pediatric and young adult patients with new diagnosis of AML.

XI. To describe the pharmacokinetic parameters of orally administered gilteritinib when administered to pediatric and young adult patients with new diagnosis of AML.

XII. To describe the pharmacodynamic parameters of gilteritinib using the FLT3 plasma inhibitory activity assay (PIA) when administered to children and young adults with new diagnosis of AML and FLT3 mutations.

XIII. To estimate OS in patients with FLT3/ITD+ AML (AR > 0.1) without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib or CPX-351-GO-gilteritinib (Separate analyses will be conducted for Arm AC vs Arm BC).

OUTLINE: Patients are randomized to either Arm A or B and assigned to Arm C or D based on FLT3 testing results.

Risk group assignments are calculated based on cytogenetic, molecular and genomic findings (details in protocol)

Risk groups include (Details in protocol):

Low Risk 1 (LR1)
Low Risk 2 (LR2)

High Risk (HR)

TREATMENT FOR PATIENTS WITHOUT FLT3 MUTATIONS:

ARM A LOW RISK GROUP 1:

INDUCTION 1: Patients receive cytarabine intravenously (IV) over 1-30 minutes every 12 hours (Q12H) on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate intrathecally (IT), therapeutic hydrocortisone (hydrocortisone) IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT once weekly (QW) starting on day 8 for 4-6 weeks (may continue into Induction 2) until the cerebral spinal fluid (CSF) is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5.

INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi intramuscularly (IM) or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.

ARM B LOW RISK GROUP 1:

INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5.

INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

INTENSIFICATION 2: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.

ARM A LOW RISK GROUP 2:

INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5.

INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15 minutes on days 3-6.

INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.

ARM B LOW RISK GROUP 2:

INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5.

INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

INTENSIFICATION 2: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4 and dexrazoxane IV over 5-15 minutes and mitoxantrone hydrochloride (mitoxantrone) IV over 5-15 minutes on days 3-6.

INTENSIFICATION 3: Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9. Patients also receive asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9.

ARM A HIGH RISK GROUP:

INDUCTION 1: Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8 and dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5.

INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

ARM B HIGH RISK GROUP:

INDUCTION 1: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2: Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5.

INTENSIFICATION 1: Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5.

HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

TREATMENT FOR PATIENTS WITH FLT3/ITD MUTATIONS (ITD AR > 0.1):

ARM AC LOW RISK GROUP 2:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO QD on days 7-27.

INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-30.

POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via nasogastric (NG) or gastronomy (G) tube daily on days 1-365.

ARM BC LOW RISK GROUP 2:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO QD on days 7-27.

INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-30.

POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

ARM AC HIGH RISK GROUP:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

ARM BC HIGH RISK GROUP:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

TREATMENT FOR NON-ITD FLT3 ACTIVATING MUTATIONS:

ARM AD LOW RISK GROUP 2:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO QD on days 7-27.

INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-30.

POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

ARM BD LOW RISK GROUP 2:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

INTENSIFICATION 2 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H on days 1-4, dexrazoxane IV over 5-15 minutes and mitoxantrone IV over 5-15 minutes on days 3-6, and gilteritinib PO QD on days 7-27.

INTENSIFICATION 3 (WITH GILTERITINIB): Patients receive high-dose cytarabine IV over 3 hours Q12H on days 1, 2, 8, and 9, asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9, and gilteritinib PO QD on days 10-30.

POST-CHEMOTHERAPY GILTERITINIB MAINTENANCE: Patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

ARM AD HIGH RISK GROUP:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive cytarabine IV over 1-30 minutes Q12H on days 1-10, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib orally (PO) once daily (QD) on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive cytarabine IV over 1-30 minutes Q12H on days 1-8, dexrazoxane IV over 5-15 minutes and daunorubicin IV over 1-15 minutes on days 1, 3, and 5, and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

ARM BD HIGH RISK GROUP:

CONTINUED INDUCTION 1 (WITH GILTERITINIB): Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, gemtuzumab ozogamicin IV over 2 hours on day 6, and gilteritinib PO QD on days 11-31. Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 8. Patients with CNS2, CNS3a, and CNS3b receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 8 for 4-6 weeks (may continue into Induction 2) until the CSF is clear of blasts (CNS1 status). Patients with CNS3c receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 1 for 6 weeks (may continue into Induction 2).

INDUCTION 2 (WITH GILTERITINIB): Patients with CNS1 receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients with CNS2 receive methotrexate IT, hydrocortisone IT, and cytarabine IT QW starting on day 0 until CNS1 status is reached. Patients also receive CPX-351 IV over 90 minutes on days 1, 3, and 5 and gilteritinib PO QD on days 11-31.

INTENSIFICATION 1 (WITH GILTERITINIB): Patients receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 0. Patients also receive high-dose cytarabine IV over 1-3 hours Q12H and etoposide IV over 90-120 minutes on days 1-5, and gilteritinib PO QD on days 6-26.

HSCT: After completion of Intensification 1 and investigator assigned conditioning regimen, patients undergo allogeneic HSCT.

POST-HSCT GILTERITINIB MAINTENANCE: Beginning 30-120 days after completion of HSCT, patients receive gilteritinib PO QD or via NG or G tube daily on days 1-365.

NOTE: During Induction 2 or Intensification 2, patients in Arms A and B with left ventricular systolic dysfunction receive a replacement course of high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9, and asparaginase Erwinia chrysanthemi IM or IV over 1-2 hours and asparaginase IM or IV over 30 minutes on days 2 and 9. Patients in Arms AC, BC, AD, and BD receive treatment as in Arms A and B and also receive gilteritinib PO QD on days 10-30 (Induction 2) or days 10-30 (Intensification 2).

All treatment continues in the absence of disease progression or unacceptable toxicity.

OPTIONAL NEUROCOGNITIVE STUDY:

Patients may complete the Cogstate assessment battery at the end of Induction 1, at the end of therapy, and at 9 and 60 months post-enrollment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures
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
ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine
ARM D: 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 D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible
NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment
NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking
NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)
NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion Criteria:

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
All-trans retinoic acid (ATRA)
Corticosteroids (any route)
Intrathecal therapy given at diagnosis
In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
ARM D: Patient does not have any congenital long QT syndrome or congenital heart block

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

1400

Study ID:

NCT04293562

Recruitment Status:

Recruiting

Sponsor:

Children's Oncology Group

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There are 195 Locations for this study

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Children's Hospital of Alabama
Birmingham Alabama, 35233, United States More Info
Site Public Contact
Contact
205-638-9285
[email protected]
Matthew A. Kutny
Principal Investigator
USA Health Strada Patient Care Center
Mobile Alabama, 36604, United States More Info
Site Public Contact
Contact
800-388-8721
Hamayun Imran
Principal Investigator
Banner Children's at Desert
Mesa Arizona, 85202, United States More Info
Site Public Contact
Contact
480-412-3100
Joseph C. Torkildson
Principal Investigator
Phoenix Childrens Hospital
Phoenix Arizona, 85016, United States More Info
Site Public Contact
Contact
602-546-0920
Dana B. Salzberg
Principal Investigator
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States More Info
Site Public Contact
Contact
[email protected]
Holly E. Pariury
Principal Investigator
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States More Info
Site Public Contact
Contact
501-364-7373
David L. Becton
Principal Investigator
Kaiser Permanente Downey Medical Center
Downey California, 90242, United States More Info
Site Public Contact
Contact
626-564-3455
Robert M. Cooper
Principal Investigator
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Site Public Contact
Contact
800-826-4673
[email protected]
Anna B. Pawlowska
Principal Investigator
Loma Linda University Medical Center
Loma Linda California, 92354, United States More Info
Site Public Contact
Contact
909-558-4050
Albert Kheradpour
Principal Investigator
Miller Children's and Women's Hospital Long Beach
Long Beach California, 90806, United States More Info
Site Public Contact
Contact
562-933-5600
Jacqueline N. Casillas
Principal Investigator
Children's Hospital Los Angeles
Los Angeles California, 90027, United States More Info
Site Public Contact
Contact
323-361-4110
Leo Mascarenhas
Principal Investigator
Cedars Sinai Medical Center
Los Angeles California, 90048, United States More Info
Site Public Contact
Contact
310-423-8965
Fataneh (Fae) Majlessipour
Principal Investigator
Mattel Children's Hospital UCLA
Los Angeles California, 90095, United States More Info
Site Public Contact
Contact
310-825-6708
Satiro N. De Oliveira
Principal Investigator
Valley Children's Hospital
Madera California, 93636, United States More Info
Site Public Contact
Contact
559-353-3000
[email protected]
Karen S. Fernandez
Principal Investigator
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States More Info
Site Public Contact
Contact
510-428-3324
[email protected]
Carla B. Golden
Principal Investigator
Kaiser Permanente-Oakland
Oakland California, 94611, United States More Info
Site Public Contact
Contact
877-642-4691
[email protected]
Aarati V. Rao
Principal Investigator
Children's Hospital of Orange County
Orange California, 92868, United States More Info
Site Public Contact
Contact
714-509-8646
[email protected]
Elyssa M. Rubin
Principal Investigator
Lucile Packard Children's Hospital Stanford University
Palo Alto California, 94304, United States More Info
Site Public Contact
Contact
800-694-0012
[email protected]
Jay Michael S. Balagtas
Principal Investigator
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Site Public Contact
Contact
916-734-3089
Marcio H. Malogolowkin
Principal Investigator
Rady Children's Hospital - San Diego
San Diego California, 92123, United States More Info
Site Public Contact
Contact
858-966-5934
William D. Roberts
Principal Investigator
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States More Info
Site Public Contact
Contact
877-827-3222
[email protected]
Benjamin J. Huang
Principal Investigator
Santa Barbara Cottage Hospital
Santa Barbara California, 93102, United States
Children's Hospital Colorado
Aurora Colorado, 80045, United States More Info
Site Public Contact
Contact
303-764-5056
[email protected]
Kelly W. Maloney
Principal Investigator
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver Colorado, 80218, United States More Info
Site Public Contact
Contact
303-839-6000
Jennifer J. Clark
Principal Investigator
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States More Info
Site Public Contact
Contact
860-545-9981
Michael S. Isakoff
Principal Investigator
Yale University
New Haven Connecticut, 06520, United States More Info
Site Public Contact
Contact
203-785-5702
[email protected]
Farzana Pashankar
Principal Investigator
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Emi H. Caywood
Principal Investigator
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
Site Public Contact
Contact
202-444-2223
Caileigh Pudela
Principal Investigator
Children's National Medical Center
Washington District of Columbia, 20010, United States More Info
Site Public Contact
Contact
202-476-2800
[email protected]
Jeffrey S. Dome
Principal Investigator
Broward Health Medical Center
Fort Lauderdale Florida, 33316, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States More Info
Site Public Contact
Contact
239-343-5333
[email protected]
Emad K. Salman
Principal Investigator
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States More Info
Site Public Contact
Contact
352-273-8010
[email protected]
William B. Slayton
Principal Investigator
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood Florida, 33021, United States More Info
Site Public Contact
Contact
954-265-1847
[email protected]
Iftikhar Hanif
Principal Investigator
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Emi H. Caywood
Principal Investigator
Palms West Radiation Therapy
Loxahatchee Groves Florida, 33470, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States More Info
Site Public Contact
Contact
305-243-2647
Julio C. Barredo
Principal Investigator
Nicklaus Children's Hospital
Miami Florida, 33155, United States More Info
Site Public Contact
Contact
888-624-2778
Ziad A. Khatib
Principal Investigator
AdventHealth Orlando
Orlando Florida, 32803, United States More Info
Site Public Contact
Contact
407-303-2090
[email protected]
Fouad M. Hajjar
Principal Investigator
Arnold Palmer Hospital for Children
Orlando Florida, 32806, United States More Info
Site Public Contact
Contact
321-841-5357
[email protected]
Amy A. Smith
Principal Investigator
Nemours Children's Hospital
Orlando Florida, 32827, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Emi H. Caywood
Principal Investigator
Sacred Heart Hospital
Pensacola Florida, 32504, United States More Info
Site Public Contact
Contact
850-416-4611
[email protected]
Erlyn C. Smith
Principal Investigator
Johns Hopkins All Children's Hospital
Saint Petersburg Florida, 33701, United States More Info
Site Public Contact
Contact
727-767-4784
[email protected]
Jennifer L. Mayer
Principal Investigator
Tampa General Hospital
Tampa Florida, 33606, United States More Info
Site Public Contact
Contact
813-844-7829
[email protected]
Andrew J. Galligan
Principal Investigator
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States More Info
Site Public Contact
Contact
813-357-0849
[email protected]
Don E. Eslin
Principal Investigator
Saint Mary's Hospital
West Palm Beach Florida, 33407, United States More Info
Site Public Contact
Contact
561-881-2815
Muaz A. Alrazzak
Principal Investigator
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States More Info
Site Public Contact
Contact
404-785-2025
[email protected]
Himalee S. Sabnis
Principal Investigator
Augusta University Medical Center
Augusta Georgia, 30912, United States More Info
Site Public Contact
Contact
706-721-2388
[email protected]
Colleen H. McDonough
Principal Investigator
Memorial Health University Medical Center
Savannah Georgia, 31404, United States More Info
Site Public Contact
Contact
912-350-7887
[email protected]
Andrew L. Pendleton
Principal Investigator
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States More Info
Site Public Contact
Contact
808-983-6090
Wade T. Kyono
Principal Investigator
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Martha M. Pacheco
Principal Investigator
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
773-880-4562
Jenna Rossoff
Principal Investigator
University of Illinois
Chicago Illinois, 60612, United States More Info
Site Public Contact
Contact
312-355-3046
Mary L. Schmidt
Principal Investigator
Loyola University Medical Center
Maywood Illinois, 60153, United States More Info
Site Public Contact
Contact
708-226-4357
Eugene Suh
Principal Investigator
Advocate Children's Hospital-Oak Lawn
Oak Lawn Illinois, 60453, United States More Info
Site Public Contact
Contact
847-723-7570
Rebecca E. McFall
Principal Investigator
Advocate Children's Hospital-Park Ridge
Park Ridge Illinois, 60068, United States More Info
Site Public Contact
Contact
[email protected]
Rebecca E. McFall
Principal Investigator
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States More Info
Site Public Contact
Contact
888-226-4343
Prerna Kumar
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
217-545-7929
Gregory P. Brandt
Principal Investigator
Riley Hospital for Children
Indianapolis Indiana, 46202, United States More Info
Site Public Contact
Contact
800-248-1199
Sandeep Batra
Principal Investigator
Ascension Saint Vincent Indianapolis Hospital
Indianapolis Indiana, 46260, United States More Info
Site Public Contact
Contact
317-338-2194
[email protected]
Bassem I. Razzouk
Principal Investigator
Blank Children's Hospital
Des Moines Iowa, 50309, United States More Info
Site Public Contact
Contact
515-241-8912
[email protected]
Samantha L. Mallory
Principal Investigator
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States More Info
Site Public Contact
Contact
800-237-1225
David S. Dickens
Principal Investigator
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
Site Public Contact
Contact
859-257-3379
James T. Badgett
Principal Investigator
Norton Children's Hospital
Louisville Kentucky, 40202, United States More Info
Site Public Contact
Contact
502-629-5500
[email protected]
Ashok B. Raj
Principal Investigator
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States More Info
Site Public Contact
Contact
[email protected]
Lolie C. Yu
Principal Investigator
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States More Info
Site Public Contact
Contact
504-842-8084
[email protected]
Craig Lotterman
Principal Investigator
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Maine Children's Cancer Program
Scarborough Maine, 04074, United States More Info
Site Public Contact
Contact
207-396-7581
[email protected]
Eric C. Larsen
Principal Investigator
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States More Info
Site Public Contact
Contact
410-601-6120
[email protected]
Jason M. Fixler
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States More Info
Site Public Contact
Contact
410-955-8804
[email protected]
Alan D. Friedman
Principal Investigator
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States More Info
Site Public Contact
Contact
301-319-2100
Allen I. Stering
Principal Investigator
Tufts Children's Hospital
Boston Massachusetts, 02111, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States More Info
Site Public Contact
Contact
877-726-5130
Howard J. Weinstein
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Site Public Contact
Contact
877-442-3324
Jessica A. Pollard
Principal Investigator
UMass Memorial Medical Center - University Campus
Worcester Massachusetts, 01655, United States More Info
Site Public Contact
Contact
508-856-3216
[email protected]
Stefanie R. Lowas
Principal Investigator
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States More Info
Site Public Contact
Contact
800-865-1125
Joshua W. Goldman
Principal Investigator
Children's Hospital of Michigan
Detroit Michigan, 48201, United States More Info
Site Public Contact
Contact
[email protected]
Sureyya Savasan
Principal Investigator
Ascension Saint John Hospital
Detroit Michigan, 48236, United States
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States More Info
Site Public Contact
Contact
517-975-9547
Laura E. Agresta
Principal Investigator
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Beaumont Children's Hospital-Royal Oak
Royal Oak Michigan, 48073, United States More Info
Site Public Contact
Contact
248-551-7695
Laura K. Gowans
Principal Investigator
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States More Info
Site Public Contact
Contact
612-813-5913
[email protected]
Michael K. Richards
Principal Investigator
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States More Info
Site Public Contact
Contact
612-624-2620
Peter M. Gordon
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Site Public Contact
Contact
855-776-0015
Mira Kohorst
Principal Investigator
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
Site Public Contact
Contact
601-815-6700
Betty L. Herrington
Principal Investigator
Columbia Regional
Columbia Missouri, 65201, United States
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States More Info
Site Public Contact
Contact
816-302-6808
[email protected]
Keith J. August
Principal Investigator
Cardinal Glennon Children's Medical Center
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Shalini Shenoy
Principal Investigator
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States More Info
Site Public Contact
Contact
314-251-7066
Robin D. Hanson
Principal Investigator
Children's Hospital and Medical Center of Omaha
Omaha Nebraska, 68114, United States More Info
Site Public Contact
Contact
402-955-3949
Jill C. Beck
Principal Investigator
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Site Public Contact
Contact
402-559-6941
[email protected]
Jill C. Beck
Principal Investigator
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Sunrise Hospital and Medical Center
Las Vegas Nevada, 89109, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Renown Regional Medical Center
Reno Nevada, 89502, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon New Hampshire, 03756, United States More Info
Site Public Contact
Contact
800-639-6918
[email protected]
Angela Ricci
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Site Public Contact
Contact
201-996-2879
Jing Chen
Principal Investigator
Morristown Medical Center
Morristown New Jersey, 07960, United States More Info
Site Public Contact
Contact
973-971-5900
Kathryn L. Laurie
Principal Investigator
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States More Info
Site Public Contact
Contact
732-745-8600
[email protected]
Nibal A. Zaghloul
Principal Investigator
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States More Info
Site Public Contact
Contact
732-235-8675
Marissa Botwinick
Principal Investigator
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States More Info
Site Public Contact
Contact
973-926-7230
[email protected]
Teena Bhatla
Principal Investigator
Saint Joseph's Regional Medical Center
Paterson New Jersey, 07503, United States More Info
Site Public Contact
Contact
973-754-2207
[email protected]
Alissa Kahn
Principal Investigator
Albany Medical Center
Albany New York, 12208, United States More Info
Site Public Contact
Contact
518-262-5513
Lauren R. Weintraub
Principal Investigator
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Lisa Gennarini
Principal Investigator
Maimonides Medical Center
Brooklyn New York, 11219, United States More Info
Site Public Contact
Contact
718-765-2500
Mahmut Y. Celiker
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Site Public Contact
Contact
800-767-9355
[email protected]
Clare J. Twist
Principal Investigator
NYU Winthrop Hospital
Mineola New York, 11501, United States More Info
Site Public Contact
Contact
212-263-4432
[email protected]
Chana L. Glasser
Principal Investigator
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park New York, 11040, United States More Info
Site Public Contact
Contact
718-470-3460
Arlene S. Redner
Principal Investigator
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States More Info
Site Public Contact
Contact
[email protected]
Elizabeth A. Raetz
Principal Investigator
Mount Sinai Hospital
New York New York, 10029, United States More Info
Site Public Contact
Contact
212-824-7309
[email protected]
Pamela R. Merola
Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Site Public Contact
Contact
212-305-6361
[email protected]
Nobuko Hijiya
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
Neerav N. Shukla
Principal Investigator
NYP/Weill Cornell Medical Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-746-1848
Alexander J. Chou
Principal Investigator
University of Rochester
Rochester New York, 14642, United States More Info
Site Public Contact
Contact
585-275-5830
Craig A. Mullen
Principal Investigator
Stony Brook University Medical Center
Stony Brook New York, 11794, United States More Info
Site Public Contact
Contact
800-862-2215
Laura E. Hogan
Principal Investigator
State University of New York Upstate Medical University
Syracuse New York, 13210, United States More Info
Site Public Contact
Contact
315-464-5476
Philip M. Monteleone
Principal Investigator
New York Medical College
Valhalla New York, 10595, United States More Info
Site Public Contact
Contact
914-594-3794
Jessica C. Hochberg
Principal Investigator
Mission Hospital
Asheville North Carolina, 28801, United States More Info
Site Public Contact
Contact
828-213-7055
[email protected]
Douglas J. Scothorn
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States More Info
Site Public Contact
Contact
877-668-0683
[email protected]
Thomas B. Alexander
Principal Investigator
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States More Info
Site Public Contact
Contact
800-804-9376
Joel A. Kaplan
Principal Investigator
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Site Public Contact
Contact
888-275-3853
Jessica M. Sun
Principal Investigator
East Carolina University
Greenville North Carolina, 27834, United States More Info
Site Public Contact
Contact
252-744-1015
[email protected]
Andrea R. Whitfield
Principal Investigator
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States More Info
Site Public Contact
Contact
336-713-6771
Thomas W. McLean
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Samuel J. Milanovich
Principal Investigator
Children's Hospital Medical Center of Akron
Akron Ohio, 44308, United States More Info
Site Public Contact
Contact
330-543-3193
Erin Wright
Principal Investigator
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States More Info
Site Public Contact
Contact
513-636-2799
[email protected]
Lauren Pommert
Principal Investigator
Rainbow Babies and Childrens Hospital
Cleveland Ohio, 44106, United States More Info
Site Public Contact
Contact
216-844-5437
Duncan S. Stearns
Principal Investigator
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Rabi Hanna
Principal Investigator
Nationwide Children's Hospital
Columbus Ohio, 43205, United States More Info
Site Public Contact
Contact
614-722-6039
[email protected]
Mark A. Ranalli
Principal Investigator
Dayton Children's Hospital
Dayton Ohio, 45404, United States More Info
Site Public Contact
Contact
800-228-4055
Mukund G. Dole
Principal Investigator
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo Ohio, 43606, United States More Info
Site Public Contact
Contact
419-824-1842
[email protected]
Jamie L. Dargart
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Rene Y. McNall-Knapp
Principal Investigator
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States More Info
Site Public Contact
Contact
503-413-2560
Janice F. Olson
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Site Public Contact
Contact
503-494-1080
[email protected]
Bill H. Chang
Principal Investigator
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Site Public Contact
Contact
570-271-5251
[email protected]
Jagadeesh Ramdas
Principal Investigator
Penn State Children's Hospital
Hershey Pennsylvania, 17033, United States More Info
Site Public Contact
Contact
717-531-6012
Lisa M. McGregor
Principal Investigator
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States More Info
Site Public Contact
Contact
267-425-5544
[email protected]
Richard Aplenc
Principal Investigator
Saint Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States More Info
Site Public Contact
Contact
215-427-8991
Gregory E. Halligan
Principal Investigator
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States More Info
Site Public Contact
Contact
412-692-8570
[email protected]
Jean M. Tersak
Principal Investigator
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Site Public Contact
Contact
401-444-1488
Jennifer J. Welch
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Site Public Contact
Contact
843-792-9321
[email protected]
Jacqueline M. Kraveka
Principal Investigator
Prisma Health Richland Hospital
Columbia South Carolina, 29203, United States More Info
Site Public Contact
Contact
864-241-6251
Stuart L. Cramer
Principal Investigator
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States More Info
Site Public Contact
Contact
864-241-6251
Aniket Saha
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Kayelyn J. Wagner
Principal Investigator
T C Thompson Children's Hospital
Chattanooga Tennessee, 37403, United States
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States More Info
Site Public Contact
Contact
865-541-8266
Susan E. Spiller
Principal Investigator
The Children's Hospital at TriStar Centennial
Nashville Tennessee, 37203, United States More Info
Site Public Contact
Contact
615-342-1919
Jennifer A. Domm
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Site Public Contact
Contact
800-811-8480
Brianna N. Smith
Principal Investigator
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States More Info
Site Public Contact
Contact
512-628-1902
[email protected]
Shannon M. Cohn
Principal Investigator
Driscoll Children's Hospital
Corpus Christi Texas, 78411, United States More Info
Site Public Contact
Contact
361-694-5311
[email protected]
Nkechi I. Mba
Principal Investigator
Medical City Dallas Hospital
Dallas Texas, 75230, United States More Info
Site Public Contact
Contact
972-566-5588
Stanton C. Goldman
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Tamra L. Slone
Principal Investigator
El Paso Children's Hospital
El Paso Texas, 79905, United States More Info
Site Public Contact
Contact
915-298-5444
[email protected]
Ranjan Bista
Principal Investigator
Cook Children's Medical Center
Fort Worth Texas, 76104, United States More Info
Site Public Contact
Contact
682-885-2103
[email protected]
Kenneth M. Heym
Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
713-798-1354
[email protected]
Alexandra M. Stevens
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Najat C. Daw
Principal Investigator
Children's Hospital of San Antonio
San Antonio Texas, 78207, United States More Info
Site Public Contact
Contact
210-704-2894
[email protected]
Timothy C. Griffin
Principal Investigator
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States More Info
Site Public Contact
Contact
210-575-6240
[email protected]
Jose M. Esquilin
Principal Investigator
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States More Info
Site Public Contact
Contact
210-450-3800
[email protected]
Anne-Marie R. Langevin
Principal Investigator
Scott and White Memorial Hospital
Temple Texas, 76508, United States More Info
Site Public Contact
Contact
254-724-5407
Nicholas W. McGregor
Principal Investigator
Primary Children's Hospital
Salt Lake City Utah, 84113, United States More Info
Site Public Contact
Contact
801-585-5270
Mallorie B. Heneghan
Principal Investigator
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States More Info
Site Public Contact
Contact
802-656-8990
[email protected]
Jessica L. Heath
Principal Investigator
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States More Info
Site Public Contact
Contact
434-243-6303
[email protected]
William C. Petersen
Principal Investigator
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States More Info
Site Public Contact
Contact
703-208-6650
[email protected]
Robin Y. Dulman
Principal Investigator
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States More Info
Site Public Contact
Contact
757-668-7243
[email protected]
Eric J. Lowe
Principal Investigator
Naval Medical Center - Portsmouth
Portsmouth Virginia, 23708, United States More Info
Site Public Contact
Contact
757-953-5939
Bethany M. Mikles
Principal Investigator
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Jordyn R. Griffin
Principal Investigator
Carilion Children's
Roanoke Virginia, 24014, United States More Info
Site Public Contact
Contact
540-266-6238
[email protected]
Erwood G. Edwards
Principal Investigator
Seattle Children's Hospital
Seattle Washington, 98105, United States More Info
Site Public Contact
Contact
866-987-2000
Sarah E. Leary
Principal Investigator
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States More Info
Site Public Contact
Contact
800-228-6618
[email protected]
Judy L. Felgenhauer
Principal Investigator
Mary Bridge Children's Hospital and Health Center
Tacoma Washington, 98405, United States More Info
Site Public Contact
Contact
253-403-1461
[email protected]
Robert G. Irwin
Principal Investigator
Madigan Army Medical Center
Tacoma Washington, 98431, United States More Info
Site Public Contact
Contact
253-968-6144
[email protected]
Melissa A. Forouhar
Principal Investigator
West Virginia University Charleston Division
Charleston West Virginia, 25304, United States More Info
Site Public Contact
Contact
304-388-9944
Mohamad H. Badawi
Principal Investigator
Saint Vincent Hospital Cancer Center Green Bay
Green Bay Wisconsin, 54301, United States More Info
Site Public Contact
Contact
920-433-8889
[email protected]
Catherine A. Long
Principal Investigator
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
Site Public Contact
Contact
800-622-8922
Kenneth B. De Santes
Principal Investigator
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States More Info
Site Public Contact
Contact
800-782-8581
[email protected]
Jon M. Brandt
Principal Investigator
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-955-4727
[email protected]
Michael J. Burke
Principal Investigator
Alberta Children's Hospital
Calgary Alberta, T3B 6, Canada More Info
Site Public Contact
Contact
403-220-6898
[email protected]
Victor A. Lewis
Principal Investigator
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada More Info
Site Public Contact
Contact
780-407-8798
[email protected]
Sarah J. McKillop
Principal Investigator
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada More Info
Site Public Contact
Contact
604-875-2345
David B. Dix
Principal Investigator
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada More Info
Site Public Contact
Contact
866-561-1026
[email protected]
Issai M. Vanan
Principal Investigator
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada More Info
Site Public Contact
Contact
902-470-8520
[email protected]
Craig Erker
Principal Investigator
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada More Info
Site Public Contact
Contact
905-521-2100
Uma H. Athale
Principal Investigator
Kingston Health Sciences Centre
Kingston Ontario, K7L 2, Canada More Info
Site Public Contact
Contact
613-549-6666
[email protected]
Laura Wheaton
Principal Investigator
Children's Hospital
London Ontario, N6A 5, Canada More Info
Site Public Contact
Contact
519-685-8306
Shayna M. Zelcer
Principal Investigator
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada More Info
Site Public Contact
Contact
613-737-7600
Donna L. Johnston
Principal Investigator
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada More Info
Site Public Contact
Contact
416-813-7654
[email protected]
Johann Hitzler
Principal Investigator
The Montreal Children's Hospital of the MUHC
Montreal Quebec, H3H 1, Canada More Info
Site Public Contact
Contact
514-412-4445
[email protected]
Sharon B. Abish
Principal Investigator
Centre Hospitalier Universitaire Sainte-Justine
Montreal Quebec, H3T 1, Canada More Info
Site Public Contact
Contact
514-345-4931
[email protected]
Monia Marzouki
Principal Investigator
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke Quebec, J1H 5, Canada More Info
Site Public Contact
Contact
819-820-6480
[email protected]
Josee Brossard
Principal Investigator
Jim Pattison Children's Hospital
Saskatoon Saskatchewan, S7N 0, Canada More Info
Site Public Contact
Contact
306-655-3544
[email protected]
Kathleen Felton
Principal Investigator
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec , G1V 4, Canada More Info
Site Public Contact
Contact
418-525-4444
[email protected]
Bruno Michon
Principal Investigator
University Pediatric Hospital
San Juan , 00926, Puerto Rico More Info
Site Public Contact
Contact
787-474-0333
Maria E. Echevarria
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

1400

Study ID:

NCT04293562

Recruitment Status:

Recruiting

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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