Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
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First Received Date ICMJE | September 26, 2006 | ||||||||
Last Updated Date | September 12, 2012 | ||||||||
Start Date ICMJE | March 2007 | ||||||||
Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00381680 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Frequency and severity of adverse effects at 3 years [ Designated as safety issue: Yes ] | ||||||||
Original Secondary Outcome Measures ICMJE |
Frequency and severity of adverse effects at 3 years | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia | ||||||||
Official Title ICMJE | Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies | ||||||||
Brief Summary | 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) and giving the drugs in different ways and different doses may kill more cancer cells. It is not yet known whether low-dose vincristine is more effective than high-dose vincristine (closed to accrual as of 09/2010) when given together with different combination chemotherapy regimens in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine(closed to accrual as of 09/2010) when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms (randomization closed as of 09/2010).
NOTE: *CNS-positive patients do not receive methotrexate IT. In both arms, CNS-positive patients receive intrathecal triple therapy (ITT) comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, 22, and 29. CNS-positive patients not achieving remission after induction therapy 1 receive one additional dose of ITT on day 36. Patients in both arms then proceed to induction therapy 2**. NOTE: **Patients who are CNS-positive at relapse receive induction therapy 3 BEFORE induction therapy 2. NOTE: *** Patients already enrolled on arm II are crossover to arm I.
NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on days 1 and 22. Patients with testicular-relapse with persistent testicular disease at the end of induction therapy 1 undergo testicular radiotherapy once daily, 5 days a week, for 12 days during induction therapy 2**. NOTE: **Radiotherapy should be completed before beginning high-dose methotrexate (week 9) chemotherapy. All patients then proceed to induction therapy 3.
Patients with a suitable HLA-matched related donor are removed from study and proceed to stem cell transplantation. Patients without a suitable HLA-matched related donor proceed to intensification therapy 1 (as per their randomized arm in induction therapy 1).
NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on day 15. ITT repeats every 3 weeks for 3 courses. NOTE: ** Patients already enrolled on arm II are crossover to arm I. Patients in both arms then proceed to reinduction therapy (as per their randomized arm in induction therapy 1).
NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on days 1 and 28. NOTE: ** Patients already enrolled on arm II are crossover to arm I. Patients in both arms then proceed to intensification therapy 2 (as per their randomized arm in induction therapy 1).
NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive ITT on day 36. Treatment repeats every 6 weeks for 3 courses. Patients in both arms then proceed to maintenance therapy (as per their randomized arm in induction therapy 1).
NOTE: *CNS-positive patients receive methotrexate IT on day 1, instead of oral methotrexate. Beginning in week 1 of the first maintenance therapy course, patients with CNS relapse undergo cranial radiotherapy once daily, 5 days a week, for 10 days. Patients with CNS relapse do not receive any IT therapy during maintenance therapy. After completion of study therapy, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 418 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 418 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
NOTE: **Testicular relapse is defined as unilateral or bilateral testiculomegaly with biopsy-proven testicular involvement OR unilateral or bilateral testiculomegaly with concurrent relapse in the bone marrow and/or CNS
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||
Ages | 1 Year to 29 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | |||||||||
Location Countries ICMJE | United States, Australia, Canada, Switzerland | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00381680 | ||||||||
Other Study ID Numbers ICMJE | CDR0000495359, COG-AALL0433 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | Gregory H. Reaman, Children's Oncology Group - Group Chair Office | ||||||||
Study Sponsor ICMJE | Children's Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | September 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |