Current Research: Pediatric Hematology-Oncology

AALL0434 -- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-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) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia.

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia.

Eligibility

Patients may be eligible for this trial if:

• Newly diagnosed T-cell acute lymphoblastic leukemia
• Concurrently enrolled on protocol COG-AALL03B1
• Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
• No peripheral neurotoxicity ≥ grade 2 (for patients randomized to receive nelarabine)
• No prior seizure disorder (for patients randomized to receive nelarabine)
• Prior steroid therapy allowed
• No prior cytotoxic chemotherapy except intrathecal cytarabine
• At least 2 years since prior and no concurrent anticonvulsant therapy (for patients randomized to receive nelarabine)
• No concurrent milk or citrus products during thioguanine or mercaptopurine administration
• No concurrent intensity-modulated radiotherapy
• No concurrent nonsteroidal anti-inflammatory drugs, penicillin, or acetylsalicyclic acid-containing medications for at least 3 days after high-dose methotrexate

Trial Sponsor

• Children’s Oncology Group (COG); National Cancer Institute (NCI)

Project Begin Date

• Aug 2007

Tentative Project End Date

• Jan 2013

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .