Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

Completed · Phase 3

Conditions studied: B-cell Childhood Acute Lymphoblastic Leukemia, L1 Childhood Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia

In brief

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 treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. 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..

Key facts

Study ID

NCT00381680

Run by

Children's Oncology Group

People needed

275

Starts

2007-03-01

Last updated by the study team

2024-03-26

Who can join

Age: 1 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Children's Oncology Group — Arcadia, California, United States
• Southern California Permanente Medical Group — Downey, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• Sutter General Hospital — Sacramento, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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