Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT03007147

Recruitment Status : Recruiting

First Posted : January 2, 2017

Last Update Posted : April 11, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

EsPhALL Network/ BFM Study Group

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Children's Oncology Group

Tracking Information

First Submitted Date ^ICMJE

December 28, 2016

First Posted Date ^ICMJE

January 2, 2017

Last Update Posted Date

April 11, 2024

Actual Study Start Date ^ICMJE

August 8, 2017

Estimated Primary Completion Date

September 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients) [ Time Frame: Up to 3 years ]

Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.

Original Primary Outcome Measures ^ICMJE

DFS [ Time Frame: Up to 3 years ]

Will compare the DFS of standard risk Ph+ ALL patients treated continuous imatinib mesylate with high risk COG/BFM ALL chemotherapy backbone or more intensive EsPhALL chemotherapy backbone.

Change History

Current Secondary Outcome Measures ^ICMJE

DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients) [ Time Frame: Up to 3 years ]
Three-year DFS (time from randomization to relapse, second malignancy, or death in complete remission) and 95% CI of SR pediatric Ph+ and ABL-class fusion positive patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 2 years ]
The proportion of patients who receive at least 75% of intended doses.
Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate [ Time Frame: Up to 3 years ]
Three-year EFS and 95% CI for high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate. EFS is defined as the time from the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event (resistant disease [MRD >= 10-2 or morphologic residual disease at end of consolidation block 3], relapse, progressive disease [i.e., MRD >= 10-2 at two post-HSCT time points separated by at least 2 weeks], second malignancy, or death in complete remission), or time to last follow-up for patients without events.
Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms [ Time Frame: Up to 3 years ]
Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The rate of infections during the post IB/pre-maintenance phases of treatment will be described for each randomization group.
EFS of all Ph+ patients [ Time Frame: Up to 3 years ]
Three-year EFS and 95% CI for Ph+ ALL patients. EFS here is defined as the time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignant, or death, whichever occurs first.
Overall survival (OS) of all Ph+ patients [ Time Frame: Up to 3 years ]
Three-year OS and 95% CI for Ph+ ALL patients. OS is defined as the time from study enrollment to death from any cause.
OS of SR Ph+ patients [ Time Frame: Up to 3 years ]
Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients
OS of SR Ph+ patients by randomization group [ Time Frame: Up to 3 years ]
Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients by randomization group: treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
OS of high risk Ph+ patients [ Time Frame: Up to 3 years ]
Three-year OS (time from the date of MRD assessment at end-IB to death from any cause) and 95% CI of HR pediatric Ph+ patients.
EFS of all eligibility ABL-class fusion positive ALL patients [ Time Frame: Up to 3 years ]
Three-year EFS (time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignancy, or death, whichever occurs first) and 95% CI of ABL-class fusion positive patients.
OS of all eligibility ABL-class fusion positive ALL patients [ Time Frame: Up to 3 years ]
Three-year OS (the time from study enrollment to death from any cause) and 95% CI of ABL-class fusion positive patients.

Original Secondary Outcome Measures ^ICMJE

DFS of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate [ Time Frame: Up to 3 years ]
The 3-year DFS for these patients will be estimated with a maximum standard error of 0.053.
Imatinib mesylate administration after allogeneic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 2 years ]
Feasibility of post-HSCT imatinib mesylate is determined based on the proportion of patients who receive at least 75% of intended doses.
Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms evaluated according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ]
The rate of infections during the post IB/pre-maintenance phases of treatment will be compared accounting for follow-up time.

Current Other Pre-specified Outcome Measures

Incidence of toxicities associated with post-HSCT administration of imatinib mesylate [ Time Frame: Up to 2 years ]
Evaluated according to NCI CTCAE version 5.0. Frequencies of target toxicities in high risk patients after the initiation of post-HSCT imatinib mesylate will be described. For the high risk patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection.
Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms [ Time Frame: Up to 3 years ]
Evaluated according to NCI CTCAE version 5.0. Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm.
MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay [ Time Frame: Up to 6 months ]
For all patients, frequencies and prognostic significance (DFS, EFS, OS) will be explored for MRD levels (i.e., MRD negative, detectable at < 5 x 10^-4, and dectectable at >= 5 x 10^-4) at end of Induction IB.
MRD in high risk Ph+ patients measured by IGH-TCR PCR and NGS assay [ Time Frame: Up to 3 years ]
The outcome of high risk Ph+ patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored.
MRD assessments made by IGH-TCR PCR assay and NGS assay [ Time Frame: Up to 3 years ]
Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be inspected.
IKZF1 gene aberrations and deletions [ Time Frame: Up to 3 years ]
For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions.
Frequency of p190 and p210 BCR-ABL1 fusion variants [ Time Frame: Up to 3 years ]
For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p190 and p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.
Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients [ Time Frame: Up to 2 years ]
Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6-mercaptopurine (6MP), and methotrexate dose-intensity.
Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 2 years ]
Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6MP, and methotrexate dose-intensity.

Original Other Pre-specified Outcome Measures

Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients [ Time Frame: Up to 12 months post-HSCT ]
Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk
Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients [ Time Frame: Up to day 168 of maintenance phase ]
Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the work
Frequency of p210 BCR-ABL1 fusion variants [ Time Frame: Up to 2 years ]
For both SR and HR risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.
IKZF1 gene aberrations and deletions [ Time Frame: Up to 2 years ]
For both SR and HR risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions.
Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms evaluated according to NCI CTCAE version 4.0 [ Time Frame: Up to 3 years ]
Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm.
Incidence of toxicities associated with post-HSCT administration of imatinib mesylate evaluated according to NCI CTCAE version 4.0 [ Time Frame: Up to 1 year post-HSCT ]
Frequencies of target toxicities in HR patients after the initiation of post-HSCT imatinib mesylate will be described. For the HR patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection.
MRD assessments made by IGH-TCR PCR assay and NGS assay [ Time Frame: Up to 2 years ]
Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be i
MRD in HR patients measured by IGH-TCR PCR and NGS assay [ Time Frame: Up to 12 months post-HSCT ]
The outcome of HR patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored.
MRD in SR patients measured by IGH-TCR PCR and NGS assay [ Time Frame: Up to 2 years ]
The proportion of patients with detectable MRD will be described, and association between MRD levels at later time points and long-term outcomes (e.g., DFS and OS) will be explored. The proportion of SR patients in each of the randomized arms at each of the time points who are not MRD-negative (i.e., MRD non-detectable), or who revert to MRD-positive (i.e., MRD value >= 5 x 10^-4) after previously attaining MRD-negative status will also be explored. Odds ratio estimates comparing the rates of not being MRD-negative at start of delayed intensification phase or MRD-positive at any subsequent mon
MRD measured by IGH-TCR PCR and NGS assay [ Time Frame: At the end of induction IA ]
For both SR and HR risk groups, frequencies and prognostic significance (overall survival [OS], DFS) will be explored for MRD negativity (< 5 x 10^-4) at end of Induction IA.

Descriptive Information

Brief Title ^ICMJE

Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Official Title ^ICMJE

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones

Brief Summary

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

Detailed Description

PRIMARY OBJECTIVE:

I. To compare disease-free survival (DFS) of standard risk (SR) pediatric Philadelphia chromosome (Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate (imatinib) combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy backbone or the more intensive European (Es)PhALL chemotherapy backbone.

SECONDARY OBJECTIVES:

I. To compare DFS of SR pediatric Ph+ and ABL-class fusion positive ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

II. To determine the feasibility of administration of imatinib after allogeneic hematopoietic stem cell transplantation (HSCT) in high risk Ph+ ALL patients.

III. To determine event-free survival (EFS) of HR pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.

IV. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients between the two randomized arms.

V. To evaluate event free survival (EFS) and overall survival (OS) of all eligible Ph+ALL patients enrolled on the study.

VI. To evaluate OS in SR Ph+ ALL patients. VII. To evaluate OS in HR Ph+ ALL patients. VIII. To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the study.

EXPLORATORY OBJECTIVES:

I. To describe the toxicities associated with post-HSCT administration of imatinib in HR Ph+ALL patients.

II. To evaluate the long-term toxicities in SR Ph+ ALL patients treated with chemotherapy plus imatinib (no transplant), overall and between both randomized arms.

III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at various time points during therapy.

IIIa. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals post-HSCT and explore the association of these measurements with long-term outcome.

IIIb. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) assay and next generation sequencing (NGS) assays.

IV. To determine prognostic significance of IKZF1 gene aberrations and deletions in Ph+ ALL.

V. To determine frequency and prognostic significance of p190 and p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.

VI. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine, and methotrexate) during the maintenance phase in SR Ph+ ALL patients.

VIa. To identify factors associated with poor adherence. VIb. To determine association between relapse risk and adherence to each oral chemotherapeutic agent (separately and combined).

VII. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and identify factors associated with poor adherence.

VIII. To compare DFS of SR ABL-class fusion positive ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.

OUTLINE:

INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days 1-14.

INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22, daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate intrathecally (IT) on day 29.

INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or subcutaneously (SC) on days 3-6, 10-13, 17-20, and 24-27, and methotrexate IT on days 10 and 24.

POST-INDUCTION THERAPY: Patients classified as standard risk are randomized to 1 of 2 arms. Patients with high risk are assigned to Arm C.

ARM A:

CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21, methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6, dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4, leucovorin calcium PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and pegaspargase or calaspargase pegol IV over 1-2 hours on day 5, and filgrastim SC on days 7-11 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21, methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin calcium PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 5-15 minutes and daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6, and filgrastim SC on days 7-11 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high dose cytarabine IV over 3 hours on days 1-3, dexamethasone PO BID or IV on days 1-5, etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6, and filgrastim SC on days 7-11 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over 1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63, cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV over 1-30 minutes or SC on days 38-41 and 45-48, and methotrexate IT on days 38 and 45in the absence of disease progression or unexpected toxicity.

INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28, methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over 1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49, cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the absence of disease progression or unexpected toxicity.

MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO once weekly (QW) and IT on days 1 and 43 of cycles 1, 2, and 3, and mercaptopurine PO on days 1-84. Cycles with imatinib mesylate and mercaptopurine repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of disease progression or unexpected toxicity.

ARM B:

INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63, vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV over 1-15 minutes on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2 hours or IM on day 4 in the absence of disease progression or unexpected toxicity.

DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56, cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours on day 43 in the absence of disease progression or unexpected toxicity.

INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 in the absence of disease progression or unexpected toxicity.

MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV for cycle 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84, methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for cycle 1 and 2). Cycles repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of disease progression or unexpected toxicity.

ARM C:

CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine, therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone, leucovorin calcium, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A Consolidation Block 1, and filgrastim SC on day 7 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine, therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate, ifosfamide, leucovorin calcium, dexrazoxane hydrochloride, daunorubicin hydrochloride, pegaspargase or calaspargase pegol, and filgrastim as Arm A Consolidation Block 2 in the absence of disease progression or unexpected toxicity.

CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide, methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase or calaspargase pegol, and filgrastim as in Arm A Consolidation Block 3, and high dose cytarabine IV over 3 hours on days 1-2 in the absence of disease progression or unexpected toxicity.

HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm A.

POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in the absence of disease progression or unexpected toxicity.

After completion of study treatment, patients are followed up every year for 3 years.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia
Mixed Phenotype Acute Leukemia
T Acute Lymphoblastic Leukemia

Intervention ^ICMJE

Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HSCT
Other Names:
- Allogeneic
- Allogeneic Hematopoietic Cell Transplantation
- Allogeneic Stem Cell Transplantation
- HSC
- HSCT
- Stem Cell Transplantation, Allogeneic
Drug: Calaspargase Pegol
Given IV
Other Names:
- Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)
- Asparlas
- Calaspargase Pegol-mknl
- EZN-2285
- SC-PEG E. Coli L-Asparaginase
- Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase
Drug: Cyclophosphamide
Given IV
Other Names:
- (-)-Cyclophosphamide
- 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
- Asta B 518
- B-518
- Carloxan
- Ciclofosfamida
- Ciclofosfamide
- Cicloxal
- Clafen
- Claphene
- CP monohydrate
- CTX
- CYCLO-cell
- Cycloblastin
- Cycloblastine
- Cyclophospham
- Cyclophosphamid monohydrate
- Cyclophosphamide Monohydrate
- Cyclophosphamidum
- Cyclophosphan
- Cyclophosphane
- Cyclophosphanum
- Cyclostin
- Cyclostine
- Cytophosphan
- Cytophosphane
- Cytoxan
- Fosfaseron
- Genoxal
- Genuxal
- Ledoxina
- Mitoxan
- Neosar
- Revimmune
- Syklofosfamid
- WR- 138719
- WR-138719
Drug: Cytarabine
Given IV, SC, or IT
Other Names:
- .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
Drug: Daunorubicin Hydrochloride
Given IV
Other Names:
- Cerubidin
- Cerubidine
- Cloridrato de Daunorubicina
- Daunoblastin
- Daunoblastina
- Daunoblastine
- Daunomycin Hydrochloride
- Daunomycin, hydrochloride
- Daunorubicin.HCl
- Daunorubicini Hydrochloridum
- FI-6339
- Ondena
- RP-13057
- Rubidomycin Hydrochloride
- Rubilem
Drug: Dexamethasone
Given PO or IV
Other Names:
- Aacidexam
- Adexone
- Aknichthol Dexa
- Alba-Dex
- Alin
- Alin Depot
- Alin Oftalmico
- Amplidermis
- Anemul mono
- Auricularum
- Auxiloson
- Baycadron
- Baycuten
- Baycuten N
- Cortidexason
- Cortisumman
- Decacort
- Decadrol
- Decadron
- Decadron DP
- Decalix
- Decameth
- Decasone R.p.
- Dectancyl
- Dekacort
- Deltafluorene
- Deronil
- Desamethasone
- Desameton
- Dexa-Mamallet
- Dexa-Rhinosan
- Dexa-Scheroson
- Dexa-sine
- Dexacortal
- Dexacortin
- Dexafarma
- Dexafluorene
- Dexalocal
- Dexamecortin
- Dexameth
- Dexamethasone Intensol
- Dexamethasonum
- Dexamonozon
- Dexapos
- Dexinoral
- Dexone
- Dinormon
- Dxevo
- Fluorodelta
- Fortecortin
- Gammacorten
- Hemady
- Hexadecadrol
- Hexadrol
- Lokalison-F
- Loverine
- Methylfluorprednisolone
- Millicorten
- Mymethasone
- Orgadrone
- Spersadex
- TaperDex
- Visumetazone
- ZoDex
Drug: Dexrazoxane Hydrochloride
Given IV
Other Names:
- Cardioxane
- Totect
- Zinecard
Drug: Doxorubicin
Given IV
Other Names:
- Adriablastin
- Hydroxydaunomycin
- Hydroxyl Daunorubicin
- Hydroxyldaunorubicin
Drug: Etoposide
Given IV
Other Names:
- Demethyl Epipodophyllotoxin Ethylidine Glucoside
- EPEG
- Lastet
- Toposar
- Vepesid
- VP 16
- VP 16-213
- VP 16213
- VP-16
- VP-16-213
- VP16
Biological: Filgrastim
Given IV
Other Names:
- Filgrastim Biosimilar Filgrastim-sndz
- Filgrastim Biosimilar Tbo-filgrastim
- Filgrastim XM02
- Filgrastim-aafi
- Filgrastim-ayow
- Filgrastim-sndz
- G-CSF
- Granix
- Neupogen
- Neutroval
- Nivestym
- r-metHuG-CSF
- Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
- Releuko
- rG-CSF
- Tbo-filgrastim
- Tevagrastim
- XM02
- Zarxio
Drug: Ifosfamide
Given IV
Other Names:
- Asta Z 4942
- Asta Z-4942
- Cyfos
- Holoxan
- Holoxane
- Ifex
- IFO
- IFO-Cell
- Ifolem
- Ifomida
- Ifomide
- Ifosfamidum
- Ifoxan
- IFX
- Iphosphamid
- Iphosphamide
- Iso-Endoxan
- Isoendoxan
- Isophosphamide
- Mitoxana
- MJF 9325
- MJF-9325
- Naxamide
- Seromida
- Tronoxal
- Z 4942
- Z-4942
Drug: Imatinib Mesylate
Given PO
Other Names:
- CGP 57148
- CGP57148B
- Gleevec
- Glivec
- STI 571
- STI-571
- STI571
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Leucovorin Calcium
Given PO or IV
Other Names:
- Adinepar
- Calcifolin
- Calcium (6S)-Folinate
- Calcium Folinate
- Calcium Leucovorin
- Calfolex
- Calinat
- Cehafolin
- Citofolin
- Citrec
- Citrovorum Factor
- Cromatonbic Folinico
- Dalisol
- Disintox
- Divical
- Ecofol
- Emovis
- Factor, Citrovorum
- Flynoken A
- Folaren
- Folaxin
- FOLI-cell
- Foliben
- Folidan
- Folidar
- Folinac
- Folinate Calcium
- Folinic acid
- Folinic Acid Calcium Salt Pentahydrate
- Folinoral
- Folinvit
- Foliplus
- Folix
- Imo
- Lederfolat
- Lederfolin
- Leucosar
- leucovorin
- Rescufolin
- Rescuvolin
- Tonofolin
- Wellcovorin
Drug: Mercaptopurine
Given PO
Other Names:
- 3H-Purine-6-thiol
- 6 MP
- 6 Thiohypoxanthine
- 6 Thiopurine
- 6-Mercaptopurine
- 6-Mercaptopurine Monohydrate
- 6-MP
- 6-Purinethiol
- 6-Thiopurine
- 6-Thioxopurine
- 6H-Purine-6-thione, 1,7-dihydro- (9CI)
- 7-Mercapto-1,3,4,6-tetrazaindene
- Alti-Mercaptopurine
- Azathiopurine
- Bw 57-323H
- Flocofil
- Ismipur
- Leukerin
- Leupurin
- Mercaleukim
- Mercaleukin
- Mercaptina
- Mercaptopurinum
- Mercapurin
- Mern
- NCI-C04886
- Puri-Nethol
- Purimethol
- Purine, 6-mercapto-
- Purine-6-thiol (8CI)
- Purine-6-thiol, monohydrate
- Purinethiol
- Purinethol
- U-4748
- WR-2785
Drug: Methotrexate
Given IT
Other Names:
- Abitrexate
- Alpha-Methopterin
- Amethopterin
- Brimexate
- CL 14377
- CL-14377
- Emtexate
- Emthexat
- Emthexate
- Farmitrexat
- Fauldexato
- Folex
- Folex PFS
- 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
Drug: Methylprednisolone
Given IV
Other Names:
- Adlone
- Caberdelta M
- DepMedalone
- Depo Moderin
- Depo-Nisolone
- Duralone
- Emmetipi
- Esametone
- Firmacort
- Medlone 21
- Medrate
- Medrol
- Medrol Veriderm
- Medrone
- Mega-Star
- Meprolone
- Methylprednisolonum
- Metilbetasone Solubile
- Metrocort
- Metypresol
- Metysolon
- Predni-M-Tablinen
- Prednilen
- Radilem
- Sieropresol
- Solpredone
- Summicort
- Urbason
- Veriderm Medrol
- Wyacort
Drug: Pegaspargase
Given IV
Other Names:
- L-Asparaginase with Polyethylene Glycol
- Oncaspar
- Oncaspar-IV
- PEG-Asparaginase
- PEG-L-Asparaginase
- PEG-L-Asparaginase (Enzon - Kyowa Hakko)
- PEGLA
- Polyethylene Glycol L-Asparaginase
- Polyethylene Glycol-L-Asparaginase
Drug: Prednisolone
Given PO
Other Names:
- (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
- .delta.1-Hydrocortisone
- Adnisolone
- Aprednislon
- Capsoid
- Cortalone
- Cortisolone
- Dacortin H
- Decaprednil
- Decortin H
- Delta(1)Hydrocortisone
- Delta- Cortef
- Delta-Cortef
- Delta-Diona
- Delta-F
- Delta-Phoricol
- Delta1-dehydro-hydrocortisone
- Deltacortril
- Deltahydrocortisone
- Deltasolone
- Deltidrosol
- Dhasolone
- Di-Adreson-F
- Dontisolon D
- Estilsona
- Fisopred
- Frisolona
- Gupisone
- Hostacortin H
- Hydeltra
- Hydeltrasol
- Klismacort
- Kuhlprednon
- Lenisolone
- Lepi-Cortinolo
- Linola-H N
- Linola-H-Fett N
- Longiprednil
- Metacortandralone
- Meti Derm
- Meticortelone
- Opredsone
- Panafcortelone
- Precortisyl
- Pred-Clysma
- Predeltilone
- Predni-Coelin
- Predni-Helvacort
- Prednicortelone
- Prednisolonum
- Prelone
- Prenilone
- Sterane
Other: Questionnaire Administration
Ancillary studies
Drug: Therapeutic Hydrocortisone
Given IT
Other Names:
- 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
Drug: Thioguanine
Given PO
Other Names:
- 2-Amino 6MP
- 2-Amino-1,7-dihydro-6H-purine-6-thione
- 2-Amino-6-mercaptopurine
- 2-Amino-6-purinethiol
- 2-Aminopurin-6-thiol
- 2-Aminopurine-6(1H)-thione
- 2-Aminopurine-6-thiol
- 2-Aminopurine-6-thiol Hemihydrate
- 2-Mercapto-6-aminopurine
- 6-Amino-2-mercaptopurine
- 6-Mercapto-2-aminopurine
- 6-Mercaptoguanine
- 6-TG
- 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
- BW 5071
- Lanvis
- Tabloid
- Thioguanine Hemihydrate
- Thioguanine Hydrate
- Tioguanin
- Tioguanine
- Wellcome U3B
- WR-1141
- X 27
Drug: Vincristine Sulfate
Given IV
Other Names:
- Kyocristine
- Leurocristine Sulfate
- Leurocristine, sulfate
- Oncovin
- Vincasar
- Vincosid
- Vincrex
- Vincristine, sulfate

Study Arms ^ICMJE

Experimental: Arm A (imatinib mesylate, EsPhALL chemotherapy)
See Detailed Description
Interventions:
- Drug: Calaspargase Pegol
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Daunorubicin Hydrochloride
- Drug: Dexamethasone
- Drug: Dexrazoxane Hydrochloride
- Drug: Doxorubicin
- Drug: Etoposide
- Biological: Filgrastim
- Drug: Ifosfamide
- Drug: Imatinib Mesylate
- Other: Laboratory Biomarker Analysis
- Drug: Leucovorin Calcium
- Drug: Mercaptopurine
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Pegaspargase
- Drug: Prednisolone
- Other: Questionnaire Administration
- Drug: Therapeutic Hydrocortisone
- Drug: Thioguanine
- Drug: Vincristine Sulfate
Experimental: Arm B (imatinib mesylate, COG/BFM chemotherapy)
See Detailed Description.
Interventions:
- Drug: Calaspargase Pegol
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Dexamethasone
- Drug: Dexrazoxane Hydrochloride
- Drug: Doxorubicin
- Drug: Imatinib Mesylate
- Other: Laboratory Biomarker Analysis
- Drug: Leucovorin Calcium
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Pegaspargase
- Drug: Prednisolone
- Other: Questionnaire Administration
- Drug: Thioguanine
- Drug: Vincristine Sulfate
Experimental: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
See Detailed Description
Interventions:
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Drug: Calaspargase Pegol
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Daunorubicin Hydrochloride
- Drug: Dexamethasone
- Drug: Dexrazoxane Hydrochloride
- Drug: Doxorubicin
- Drug: Etoposide
- Biological: Filgrastim
- Drug: Ifosfamide
- Drug: Imatinib Mesylate
- Other: Laboratory Biomarker Analysis
- Drug: Leucovorin Calcium
- Drug: Mercaptopurine
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Methylprednisolone
- Drug: Pegaspargase
- Drug: Prednisolone
- Other: Questionnaire Administration
- Drug: Therapeutic Hydrocortisone
- Drug: Thioguanine
- Drug: Vincristine Sulfate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

475

Original Estimated Enrollment ^ICMJE

700

Estimated Study Completion Date ^ICMJE

September 30, 2027

Estimated Primary Completion Date

September 30, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or ABL-class fusion must be submitted for rapid central review within 72 hours of study enrollment
>= 1 year (365 days) and =< 21 years at ALL diagnosis
Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or molecular methodologies
ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization (FISH, e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)
Ph+ patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
Ph+ patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vinCRIStine
Ph+ patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy (Induction IA phase)
ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vinCRIStine dose
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
Direct bilirubin =< 2.0 mg/dL
Shortening fraction of >= 27% by echocardiogram
Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis, before study enrollment
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

Exclusion Criteria:

Known history of chronic myelogenous leukemia (CML)
ALL developing after a previous cancer treated with cytotoxic chemotherapy
Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
Down syndrome
Pregnancy and breast feeding
- 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 treatment according to protocol
Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
Prior treatment with dasatinib, or any TKI other than imatinib

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

1 Year to 21 Years (Child, Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Listed Location Countries ^ICMJE

Australia, Austria, Belgium, Canada, Chile, Czechia, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Sweden, Switzerland, United States

Removed Location Countries

China, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT03007147

Other Study ID Numbers ^ICMJE

AALL1631
NCI-2016-01588 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AALL1631
2017-000705-20 ( EudraCT Number )
AALL1631 ( Other Identifier: Children's Oncology Group )
AALL1631 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Children's Oncology Group

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Children's Oncology Group

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

EsPhALL Network/ BFM Study Group
National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:	Lewis B Silverman	Children's Oncology Group
Principal Investigator:	Prof. Andrea Biondi	EsPhALL Network/ BFM Study Group

PRS Account

Children's Oncology Group

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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