Status:
COMPLETED
Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
B-cell Childhood Acute Lymphoblastic Leukemia
L1 Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-29 years
Phase:
PHASE3
Brief Summary
This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in tr...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia....
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of acute lymphoblastic leukemia (ALL)
- Bone marrow with \> 25% L1 or L2 lymphoblasts (M3 marrow)
- Patients with \> 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
- Intermediate-risk relapsed disease, meeting 1 of the following criteria:
- Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
- Combined bone marrow and extramedullary (CNS\* and/or testicular\*\*) relapse ≥ 36 months after initial diagnosis
- Isolated extramedullary (CNS\* and/or testicular\*\*) relapse \< 18 months after initial diagnosis
- The following subtypes are not allowed:
- T-lineage ALL
- Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
- Philadelphia-chromosome positive disease
- No Down syndrome (trisomy 21)
- Shortening fraction \>= 27% by echocardiogram OR ejection fraction \>= 50% by radionuclide angiogram
- Bilirubin \< 3.0 mg/dL
- Not pregnant
- Fertile patients must use effective contraception
- No history of peripheral neuropathy \>= grade 3 within the past month
- No toxicity (i.e. peripheral neuropathy) \>= grade 3 attributable to vincristine within the past month
- At least 5 days since prior intrathecal chemotherapy
- No prior hematopoietic stem cell or marrow transplantation
- No prior cranial radiotherapy \> 1200 cGy (for patients with CNS relapse)
- No concurrent stem cell transplant
- No concurrent alternative therapy
- No concurrent itraconazole in patients receiving vincristine
- No concurrent intensity-modulated radiotherapy
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00381680
Start Date
March 1 2007
Last Update
March 26 2024
Active Locations (173)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
3
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
4
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724