Yükleniyor... / Loading...
This study looks at using low-dose or high-dose vincristine together with several chemotherapy drugs in young patients with relapsed B-cell acute lymphoblastic leukemia. Young patients with intermediate-risk relapsed acute lymphoblastic leukemia were able to take part. Sponsored by the Children's Oncology Group, the study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
+133
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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