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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00103285 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: pegaspargase Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Standard Risk B-precursor Acute Lymphoblastic Leukemia |
| Estimated Enrollment: | 3381 |
| Study Start Date: | January 2005 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1 (SR-low ALL), arm I
Patients receive Part I therapy. Patients then receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Experimental: Group 1 (SR-low ALL), arm II
Patients receive Part I therapy. Patients then receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Active Comparator: Group 2 (SR-average ALL), arm I
Patients receive Part I therapy. Patients then receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Experimental: Group 2 (SR-average ALL), arm II
Patients receive Part I therapy. Patients then receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Active Comparator: Group 2 (SR-average ALL), arm III
Patients receive Part I therapy. Patients then receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Active Comparator: Group 2 (SR-average ALL), arm IV
Patients receive Part I therapy. Patients then receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Experimental: Group 3 (SR-high ALL)
Patients receive Part I therapy. Patients then receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
|
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given intrathecally, IV, or subcutaneously
Drug: dexamethasone
Given IV or orally
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given orally
Drug: mercaptopurine
Given orally
Drug: methotrexate
Given IV, orally, or intrathecally
Drug: pegaspargase
Given intramuscularly
Drug: thioguanine
Given orally
Drug: vincristine sulfate
Given IV
Radiation: radiation therapy
Some patients undergo cranial radiotherapy
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed B-precursor acute lymphoblastic leukemia
Standard-risk (SR) disease meeting 1 of the following criteria:
SR-average by age and WBC
SR-low by age and WBC
SR-high
Unfavorable features meeting ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 199 Study Locations| Study Chair: | Kelly Maloney, MD | Children's Hospital Center for Cancer and Blood Disorders |
| Investigator: | Leonard A. Mattano, MD | Bronson Methodist Hospital |
| Investigator: | Linda C. Stork, MD | Doernbecher Children's Hospital at Oregon Health and Science University |
More Information
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00103285 History of Changes |
| Other Study ID Numbers: | CDR0000409589, COG-AALL0331 |
| Study First Received: | February 7, 2005 |
| Last Updated: | December 30, 2010 |
| Health Authority: | United States: Federal Government |
|
untreated childhood acute lymphoblastic leukemia B-cell childhood acute lymphoblastic leukemia |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Pegaspargase |
Dexamethasone Doxorubicin Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |