Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT ID: NCT03007147
Last Updated: 2025-10-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
475 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-08-08
Study Completion Date
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia
NCT03147612
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia With BCR-ABL1
+3 more
ACTIVE_NOT_RECRUITING
PHASE2
Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
NCT00036738
Adult Acute Lymphoblastic Leukemia in Remission
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Blastic Phase
+7 more
COMPLETED
PHASE2
Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
NCT03959085
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
Central Nervous System Leukemia
+2 more
RECRUITING
PHASE3
Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT01256398
Acute Lymphoblastic Leukemia
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
COMPLETED
PHASE2
Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia
NCT00004056
Leukemia
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 (HR) 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 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 and validate if IKZF1 deletions alone (IKZF1del) or with other transcription factor deletions (ie, IKZF1 plus subtype \[IKZF1plus\]) or other identified genetic lesions predict poor outcomes in Ph+/ABL-class Ph-like ALL in patients treated on AALL1631.
V. To determine the frequency and prognostic significance of p190 and p210 BCR::ABL1 fusion variants in pediatric Ph+ ALL/ABL-class Ph-like 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.
IX. To determine the potential therapeutic impact of major secondary events via pharmacologic inhibitor screens in existing/engineered cell models of Ph+ and ABL-class Ph-like ALL harboring secondary events and to test the in vivo activity of the most compelling candidate compounds from pilot studies using patient-derived xenograft (PDX) models established from Ph+ and ABL-class Ph-like ALL samples collected from patients treated on AALL1631.
X. To decipher the molecular and cellular heterogeneity of chronic myelogenous leukemia (CML)-like versus typical Ph+ ALL via single-cell genomics and functional assays and investigate CML-like phenotypes via single-cell ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) sequencing to identify distinct transcriptomic and mutational profiles that will provide novel opportunities for diagnostic and therapeutic interventions.
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 or levoleucovorin 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 or IV 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 or levoleucovorin PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 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 or IV 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 or IV 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 15 minutes, and doxorubicin IV over 3-15 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 15 minutes, and doxorubicin IV over 3-15 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 or levoleucovorin 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 15 minutes, and doxorubicin IV over 3-15 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 23 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 or levoleucovorin, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A Consolidation Block 1, and filgrastim SC or IV 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 or levoleucovorin, 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.
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 (HR) 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 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 and validate if IKZF1 deletions alone (IKZF1del) or with other transcription factor deletions (ie, IKZF1 plus subtype \[IKZF1plus\]) or other identified genetic lesions predict poor outcomes in Ph+/ABL-class Ph-like ALL in patients treated on AALL1631.
V. To determine the frequency and prognostic significance of p190 and p210 BCR::ABL1 fusion variants in pediatric Ph+ ALL/ABL-class Ph-like 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.
IX. To determine the potential therapeutic impact of major secondary events via pharmacologic inhibitor screens in existing/engineered cell models of Ph+ and ABL-class Ph-like ALL harboring secondary events and to test the in vivo activity of the most compelling candidate compounds from pilot studies using patient-derived xenograft (PDX) models established from Ph+ and ABL-class Ph-like ALL samples collected from patients treated on AALL1631.
X. To decipher the molecular and cellular heterogeneity of chronic myelogenous leukemia (CML)-like versus typical Ph+ ALL via single-cell genomics and functional assays and investigate CML-like phenotypes via single-cell ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) sequencing to identify distinct transcriptomic and mutational profiles that will provide novel opportunities for diagnostic and therapeutic interventions.
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 or levoleucovorin 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 or IV 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 or levoleucovorin PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 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 or IV 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 or IV 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 15 minutes, and doxorubicin IV over 3-15 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 15 minutes, and doxorubicin IV over 3-15 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 or levoleucovorin 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 15 minutes, and doxorubicin IV over 3-15 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 23 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 or levoleucovorin, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A Consolidation Block 1, and filgrastim SC or IV 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 or levoleucovorin, 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia
Mixed Phenotype Acute Leukemia
T Acute Lymphoblastic Leukemia
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (imatinib mesylate, EsPhALL chemotherapy)
See Detailed Description
Group Type
EXPERIMENTAL
Calaspargase Pegol
Intervention Type
DRUG
Given IV
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IV, SC, or IT
Daunorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Dexamethasone
Intervention Type
DRUG
Given PO or IV
Dexrazoxane Hydrochloride
Intervention Type
DRUG
Given IV
Doxorubicin
Intervention Type
DRUG
Given IV
Etoposide
Intervention Type
DRUG
Given IV
Filgrastim
Intervention Type
BIOLOGICAL
Given SC or IV
Ifosfamide
Intervention Type
DRUG
Given IV
Imatinib Mesylate
Intervention Type
DRUG
Given PO
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Leucovorin Calcium
Intervention Type
DRUG
Given PO or IV
Levoleucovorin
Intervention Type
DRUG
Given PO or IV
Mercaptopurine
Intervention Type
DRUG
Given PO
Mercaptopurine
Intervention Type
DRUG
Given PO
Methotrexate
Intervention Type
DRUG
Given IT
Methylprednisolone
Intervention Type
DRUG
Given IV
Pegaspargase
Intervention Type
DRUG
Given IV
Prednisolone
Intervention Type
DRUG
Given PO
Questionnaire Administration
Intervention Type
OTHER
Ancillary studies
Therapeutic Hydrocortisone
Intervention Type
DRUG
Given IT
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Arm B (imatinib mesylate, COG/BFM chemotherapy)
See Detailed Description.
Group Type
EXPERIMENTAL
Calaspargase Pegol
Intervention Type
DRUG
Given IV
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IV, SC, or IT
Dexamethasone
Intervention Type
DRUG
Given PO or IV
Dexrazoxane Hydrochloride
Intervention Type
DRUG
Given IV
Doxorubicin
Intervention Type
DRUG
Given IV
Imatinib Mesylate
Intervention Type
DRUG
Given PO
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Leucovorin Calcium
Intervention Type
DRUG
Given PO or IV
Levoleucovorin
Intervention Type
DRUG
Given PO or IV
Mercaptopurine
Intervention Type
DRUG
Given PO
Methotrexate
Intervention Type
DRUG
Given IT
Methylprednisolone
Intervention Type
DRUG
Given IV
Pegaspargase
Intervention Type
DRUG
Given IV
Prednisolone
Intervention Type
DRUG
Given PO
Questionnaire Administration
Intervention Type
OTHER
Ancillary studies
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
See Detailed Description
Group Type
EXPERIMENTAL
Allogeneic Hematopoietic Stem Cell Transplantation
Intervention Type
PROCEDURE
Undergo HSCT
Calaspargase Pegol
Intervention Type
DRUG
Given IV
Cyclophosphamide
Intervention Type
DRUG
Given IV
Cytarabine
Intervention Type
DRUG
Given IV, SC, or IT
Daunorubicin Hydrochloride
Intervention Type
DRUG
Given IV
Dexamethasone
Intervention Type
DRUG
Given PO or IV
Dexrazoxane Hydrochloride
Intervention Type
DRUG
Given IV
Doxorubicin
Intervention Type
DRUG
Given IV
Etoposide
Intervention Type
DRUG
Given IV
Filgrastim
Intervention Type
BIOLOGICAL
Given SC or IV
Ifosfamide
Intervention Type
DRUG
Given IV
Imatinib Mesylate
Intervention Type
DRUG
Given PO
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Leucovorin Calcium
Intervention Type
DRUG
Given PO or IV
Levoleucovorin
Intervention Type
DRUG
Given PO or IV
Mercaptopurine
Intervention Type
DRUG
Given PO
Mercaptopurine
Intervention Type
DRUG
Given PO
Methotrexate
Intervention Type
DRUG
Given IT
Methylprednisolone
Intervention Type
DRUG
Given IV
Pegaspargase
Intervention Type
DRUG
Given IV
Prednisolone
Intervention Type
DRUG
Given PO
Questionnaire Administration
Intervention Type
OTHER
Ancillary studies
Therapeutic Hydrocortisone
Intervention Type
DRUG
Given IT
Thioguanine
Intervention Type
DRUG
Given PO
Vincristine Sulfate
Intervention Type
DRUG
Given IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo HSCT
Intervention Type
PROCEDURE
Calaspargase Pegol
Given IV
Intervention Type
DRUG
Cyclophosphamide
Given IV
Intervention Type
DRUG
Cytarabine
Given IV, SC, or IT
Intervention Type
DRUG
Daunorubicin Hydrochloride
Given IV
Intervention Type
DRUG
Dexamethasone
Given PO or IV
Intervention Type
DRUG
Dexrazoxane Hydrochloride
Given IV
Intervention Type
DRUG
Doxorubicin
Given IV
Intervention Type
DRUG
Etoposide
Given IV
Intervention Type
DRUG
Filgrastim
Given SC or IV
Intervention Type
BIOLOGICAL
Ifosfamide
Given IV
Intervention Type
DRUG
Imatinib Mesylate
Given PO
Intervention Type
DRUG
Laboratory Biomarker Analysis
Correlative studies
Intervention Type
OTHER
Leucovorin Calcium
Given PO or IV
Intervention Type
DRUG
Levoleucovorin
Given PO or IV
Intervention Type
DRUG
Mercaptopurine
Given PO
Intervention Type
DRUG
Mercaptopurine
Given PO
Intervention Type
DRUG
Methotrexate
Given IT
Intervention Type
DRUG
Methylprednisolone
Given IV
Intervention Type
DRUG
Pegaspargase
Given IV
Intervention Type
DRUG
Prednisolone
Given PO
Intervention Type
DRUG
Questionnaire Administration
Ancillary studies
Intervention Type
OTHER
Therapeutic Hydrocortisone
Given IT
Intervention Type
DRUG
Thioguanine
Given PO
Intervention Type
DRUG
Vincristine Sulfate
Given IV
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Allogeneic
Allogeneic Hematopoietic Cell Transplantation
Allogeneic Stem Cell Transplantation
HSC
HSCT
Stem Cell Transplantation, Allogeneic
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
(-)-Cyclophosphamide
2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
Asta B 518
B 518
B-518
B518
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
CP monohydrate
CTX
CYCLO-cell
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclophosphanum
Cyclostin
Cyclostine
Cytophosphan
Cytophosphane
Cytoxan
Fosfaseron
Genoxal
Genuxal
Ledoxina
Mitoxan
Neosar
Revimmune
Syklofosfamid
WR 138719
WR- 138719
WR-138719
WR138719
.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
Cerubidin
Cerubidine
Cloridrato de Daunorubicina
Daunoblastin
Daunoblastina
Daunoblastine
Daunomycin Hydrochloride
Daunomycin, hydrochloride
Daunorubicin.HCl
Daunorubicini Hydrochloridum
FI-6339
Ondena
RP-13057
Rubidomycin Hydrochloride
Rubilem
Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
Baycuten
Baycuten N
Cortidexason
Cortisumman
Decacort
Decadrol
Decadron
Decadron DP
Decalix
Decameth
Decasone R.p.
Dectancyl
Dekacort
Deltafluorene
Deronil
Desamethasone
Desameton
Dexa-Mamallet
Dexa-Rhinosan
Dexa-Scheroson
Dexa-sine
Dexacortal
Dexacortin
Dexafarma
Dexafluorene
Dexalocal
Dexamecortin
Dexameth
Dexamethasone Intensol
Dexamethasonum
Dexamonozon
Dexapos
Dexinoral
Dexone
Dinormon
Dxevo
Fluorodelta
Fortecortin
Gammacorten
Hemady
Hexadecadrol
Hexadrol
LenaDex
Lokalison-F
Loverine
Methylfluorprednisolone
Millicorten
Mymethasone
Orgadrone
Spersadex
TaperDex
Visumetazone
ZoDex
Cardioxane
Totect
Zinecard
Adriablastin
Hydroxydaunomycin
Hydroxyl Daunorubicin
Hydroxyldaunorubicin
Demethyl Epipodophyllotoxin Ethylidine Glucoside
EPEG
Lastet
Toposar
Vepesid
VP 16
VP 16-213
VP 16213
VP-16
VP-16-213
VP-16213
VP16
VP16213
Filgrastim Biosimilar Filgrastim-sndz
Filgrastim Biosimilar Tbo-filgrastim
Filgrastim XM02
Filgrastim-aafi
Filgrastim-ayow
Filgrastim-sndz
G-CSF
Granix
Neupogen
Neutroval
Nivestim
Nivestym
r-metHuG-CSF
Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
Releuko
rG-CSF
Tbo-filgrastim
Tevagrastim
XM02
Zarxio
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
CGP 57148
CGP 57148B
CGP-57148
CGP-57148B
CGP57148
CGP57148B
Gleevec
Glivec
Imarech
Imat
Imkeldi
STI 571
STI-571
STI571
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
CL-307,782
Elvorine, Isovorin, Levofolene, Levorin
Isovorin
L-Leucovorin
Levofolinate
Levofolinic acid
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
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
Abitrexate
Alpha-Methopterin
Amethopterin
Brimexate
CL 14377
CL-14377
Emtexate
Emthexat
Emthexate
Farmitrexat
Fauldexato
Folex
Folex PFS
Jylamvo
Lantarel
Ledertrexate
Lumexon
Maxtrex
Medsatrexate
Metex
Methoblastin
Methotrexate LPF
Methotrexate Methylaminopterin
Methotrexatum
Metotrexato
Metrotex
Mexate
Mexate-AQ
MTX
Novatrex
Rheumatrex
Texate
Tremetex
Trexeron
Trixilem
WR-19039
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
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
(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
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
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
Kyocristine
Leurocristine Sulfate
Leurocristine, sulfate
Oncovin
Vincasar
Vincosid
Vincrex
Vincristine, sulfate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 RNA-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, California \[CA\], United States of America \[USA\] 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)
* 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 RNA-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, California \[CA\], United States of America \[USA\] 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
* 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
Minimum Eligible Age
1 Year
Maximum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EsPhALL
OTHER
Sponsor Role
collaborator
National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Children's Oncology Group
NETWORK
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lewis B Silverman
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Prof. Andrea Biondi
Role: PRINCIPAL_INVESTIGATOR
EsPhALL Network/ BFM Study Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mission Hospital
Asheville, North Carolina, United States
Site Status
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Site Status
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Site Status
Children's Hospital of Alabama
Birmingham, Alabama, United States
Site Status
USA Health Strada Patient Care Center
Mobile, Alabama, United States
Site Status
Providence Alaska Medical Center
Anchorage, Alaska, United States
Site Status
Banner Children's at Desert
Mesa, Arizona, United States
Site Status
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Site Status
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Site Status
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Site Status
Kaiser Permanente Downey Medical Center
Downey, California, United States
Site Status
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Site Status
Loma Linda University Medical Center
Loma Linda, California, United States
Site Status
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Site Status
Children's Hospital Los Angeles
Los Angeles, California, United States
Site Status
Cedars Sinai Medical Center
Los Angeles, California, United States
Site Status
Valley Children's Hospital
Madera, California, United States
Site Status
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Site Status
Kaiser Permanente-Oakland
Oakland, California, United States
Site Status
Children's Hospital of Orange County
Orange, California, United States
Site Status
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Site Status
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Site Status
Rady Children's Hospital - San Diego
San Diego, California, United States
Site Status
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Site Status
Children's Hospital Colorado
Aurora, Colorado, United States
Site Status
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
Site Status
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Site Status
Yale University
New Haven, Connecticut, United States
Site Status
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Site Status
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Site Status
Children's National Medical Center
Washington D.C., District of Columbia, United States
Site Status
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Site Status
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Site Status
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Site Status
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Site Status
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
Site Status
Palms West Radiation Therapy
Loxahatchee Groves, Florida, United States
Site Status
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Site Status
Nicklaus Children's Hospital
Miami, Florida, United States
Site Status
Miami Cancer Institute
Miami, Florida, United States
Site Status
AdventHealth Orlando
Orlando, Florida, United States
Site Status
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Site Status
Nemours Children's Hospital
Orlando, Florida, United States
Site Status
Sacred Heart Hospital
Pensacola, Florida, United States
Site Status
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Site Status
Tampa General Hospital
Tampa, Florida, United States
Site Status
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
Site Status
Saint Mary's Medical Center
West Palm Beach, Florida, United States
Site Status
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Site Status
Augusta University Medical Center
Augusta, Georgia, United States
Site Status
Atrium Health Navicent
Macon, Georgia, United States
Site Status
Memorial Health University Medical Center
Savannah, Georgia, United States
Site Status
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Site Status
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Site Status
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Site Status
University of Illinois
Chicago, Illinois, United States
Site Status
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Site Status
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Site Status
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States
Site Status
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
Site Status
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Site Status
Riley Hospital for Children
Indianapolis, Indiana, United States
Site Status
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Site Status
Blank Children's Hospital
Des Moines, Iowa, United States
Site Status
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Site Status
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Site Status
Norton Children's Hospital
Louisville, Kentucky, United States
Site Status
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Site Status
Eastern Maine Medical Center
Bangor, Maine, United States
Site Status
Maine Children's Cancer Program
Scarborough, Maine, United States
Site Status
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Site Status
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Site Status
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Site Status
Tufts Children's Hospital
Boston, Massachusetts, United States
Site Status
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Site Status
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Site Status
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Site Status
Children's Hospital of Michigan
Detroit, Michigan, United States
Site Status
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Site Status
Michigan State University
East Lansing, Michigan, United States
Site Status
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Site Status
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Site Status
Corewell Health Children's
Royal Oak, Michigan, United States
Site Status
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Site Status
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Site Status
University of Mississippi Medical Center
Jackson, Mississippi, United States
Site Status
University of Missouri Children's Hospital
Columbia, Missouri, United States
Site Status
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Site Status
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
Site Status
University of Nebraska Medical Center
Omaha, Nebraska, United States
Site Status
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Site Status
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Site Status
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Site Status
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Site Status
Renown Regional Medical Center
Reno, Nevada, United States
Site Status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Site Status
Hackensack University Medical Center
Hackensack, New Jersey, United States
Site Status
Morristown Medical Center
Morristown, New Jersey, United States
Site Status
Jersey Shore Medical Center
Neptune City, New Jersey, United States
Site Status
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Site Status
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Site Status
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Site Status
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Site Status
Presbyterian Hospital
Albuquerque, New Mexico, United States
Site Status
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Site Status
Albany Medical Center
Albany, New York, United States
Site Status
Maimonides Medical Center
Brooklyn, New York, United States
Site Status
Roswell Park Cancer Institute
Buffalo, New York, United States
Site Status
NYU Langone Hospital - Long Island
Mineola, New York, United States
Site Status
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Site Status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Site Status
Mount Sinai Hospital
New York, New York, United States
Site Status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Site Status
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Site Status
University of Rochester
Rochester, New York, United States
Site Status
Stony Brook University Medical Center
Stony Brook, New York, United States
Site Status
State University of New York Upstate Medical University
Syracuse, New York, United States
Site Status
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Site Status
New York Medical College
Valhalla, New York, United States
Site Status
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
East Carolina University
Greenville, North Carolina, United States
Site Status
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Site Status
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Site Status
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States
Site Status
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
Nationwide Children's Hospital
Columbus, Ohio, United States
Site Status
Dayton Children's Hospital
Dayton, Ohio, United States
Site Status
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, United States
Site Status
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Site Status
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Site Status
Oregon Health and Science University
Portland, Oregon, United States
Site Status
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Site Status
Geisinger Medical Center
Danville, Pennsylvania, United States
Site Status
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Site Status
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Site Status
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Site Status
Rhode Island Hospital
Providence, Rhode Island, United States
Site Status
Medical University of South Carolina
Charleston, South Carolina, United States
Site Status
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Site Status
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Site Status
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Site Status
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
Site Status
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Site Status
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States
Site Status
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Site Status
Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, United States
Site Status
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Site Status
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Site Status
Medical City Dallas Hospital
Dallas, Texas, United States
Site Status
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Site Status
El Paso Children's Hospital
El Paso, Texas, United States
Site Status
Cook Children's Medical Center
Fort Worth, Texas, United States
Site Status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Site Status
M D Anderson Cancer Center
Houston, Texas, United States
Site Status
Covenant Children's Hospital
Lubbock, Texas, United States
Site Status
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States
Site Status
Children's Hospital of San Antonio
San Antonio, Texas, United States
Site Status
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Site Status
Scott and White Memorial Hospital
Temple, Texas, United States
Site Status
Primary Children's Hospital
Salt Lake City, Utah, United States
Site Status
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Site Status
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Site Status
Inova Fairfax Hospital
Falls Church, Virginia, United States
Site Status
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Site Status
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States
Site Status
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Site Status
Carilion Children's
Roanoke, Virginia, United States
Site Status
Seattle Children's Hospital
Seattle, Washington, United States
Site Status
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Site Status
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States
Site Status
Madigan Army Medical Center
Tacoma, Washington, United States
Site Status
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Site Status
West Virginia University Healthcare
Morgantown, West Virginia, United States
Site Status
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Site Status
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Site Status
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Site Status
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, Australia
Site Status
Sydney Children's Hospital
Randwick, New South Wales, Australia
Site Status
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Site Status
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Site Status
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Site Status
Perth Children's Hospital
Perth, Western Australia, Australia
Site Status
St. Anna Children's Hospital
Vienna, , Austria
Site Status
Hospitals Leuven
Leuven, Flemish Brabant, Belgium
Site Status
Alberta Children's Hospital
Calgary, Alberta, Canada
Site Status
University of Alberta Hospital
Edmonton, Alberta, Canada
Site Status
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Site Status
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Site Status
IWK Health Centre
Halifax, Nova Scotia, Canada
Site Status
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Site Status
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Site Status
Children's Hospital
London, Ontario, Canada
Site Status
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Site Status
Hospital for Sick Children
Toronto, Ontario, Canada
Site Status
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Site Status
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Site Status
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Site Status
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada
Site Status
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Site Status
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, , Canada
Site Status
Hospital Roberto del Rio-Universidad de Chile
Santiago, , Chile
Site Status
University Hospital Motol
Prague, , Czechia
Site Status
Tampere University Hospital
Tampere, , Finland
Site Status
CHU Hopital Sud
Rennes, , France
Site Status
University Medical Center chleswig- Campus Kiel
Kiel, Schleswig-Holstein, Germany
Site Status
Universitätsklinik Eppendorf
Hamburg, , Germany
Site Status
Hong Kong Children's Hospital
Kowloon Bay, Kowloon, Hong Kong
Site Status
Schneider Children's Medical Center of Israel
Petah Tikva, Central District, Israel
Site Status
Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM
Monza, , Italy
Site Status
Princess Máxima Center for Pediatric Oncology
Utrecht, , Netherlands
Site Status
Starship Children's Hospital
Grafton, Auckland, New Zealand
Site Status
Christchurch Hospital
Christchurch, , New Zealand
Site Status
HIMA San Pablo Oncologic Hospital
Caguas, , Puerto Rico
Site Status
San Jorge Children's Hospital
San Juan, , Puerto Rico
Site Status
University Pediatric Hospital
San Juan, , Puerto Rico
Site Status
King Faisal Specialist Hospital and Research Centre
Riyadh, , Saudi Arabia
Site Status
Skane University Hospital
Lund, Skåne County, Sweden
Site Status
University Children's Hospital
Zurich, , Switzerland
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Australia
Austria
Belgium
Canada
Chile
Czechia
Finland
France
Germany
Hong Kong
Israel
Italy
Netherlands
New Zealand
Puerto Rico
Saudi Arabia
Sweden
Switzerland
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2016-01588
Identifier Type: REGISTRY
Identifier Source: secondary_id
AALL1631
Identifier Type: -
Identifier Source: secondary_id
2017-000705-20
Identifier Type: -
Identifier Source: secondary_id
AALL1631
Identifier Type: OTHER
Identifier Source: secondary_id
AALL1631
Identifier Type: OTHER
Identifier Source: secondary_id
AALL1631
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
NCT00458848
COMPLETED
PHASE2
Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
NCT00003145
COMPLETED
PHASE2
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
NCT06247787
RECRUITING
PHASE1
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT00005596
COMPLETED
PHASE3
Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML
NCT02094794
ACTIVE_NOT_RECRUITING
PHASE2
Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
NCT03150693
SUSPENDED
PHASE3
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
NCT00005603
COMPLETED
PHASE3
Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia
NCT00005945
COMPLETED
PHASE3
Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL
NCT06175702
NOT_YET_RECRUITING
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
NCT01190930
ACTIVE_NOT_RECRUITING
PHASE3
Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant
NCT02333162
RECRUITING
PHASE1
Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia
NCT02003222
ACTIVE_NOT_RECRUITING
PHASE3
Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
NCT00002798
COMPLETED
PHASE3
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
NCT00061945
COMPLETED
PHASE1/PHASE2
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
NCT02981628
RECRUITING
PHASE2
Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders
NCT00856388
COMPLETED
NA
Total Marrow and Lymphoid Irradiation, Fludarabine, and Melphalan Before Donor Stem Cell Transplant in Treating Participants With High-Risk Acute Leukemia or Myelodysplastic Syndrome
NCT03494569
RECRUITING
PHASE1
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
NCT00408005
COMPLETED
PHASE3
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT00103285
COMPLETED
PHASE3
Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Leukemia
NCT02446964
COMPLETED
PHASE1
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT02883049
ACTIVE_NOT_RECRUITING
PHASE3
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
NCT00022126
COMPLETED
PHASE2
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
NCT04293562
RECRUITING
PHASE3
AZD1775 in Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myelofibrosis
NCT03718143
TERMINATED
PHASE2
Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia
NCT01424982
ACTIVE_NOT_RECRUITING
PHASE2