Current Research: Pediatric Hematology-Oncology

AALL0331 -- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed 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.
This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia.

Eligibility

Patients may be eligible for this trial if:

• Newly diagnosed B-precursor acute lymphoblastic leukemia
• Standard-risk (SR) disease meeting one of the following criteria:
  • SR-average by age and WB
    • No unfavorable features
    • Rapid early responder (RER) by day 15
    • CNS 1 or 2
    • Minimal residual disease (MRD) negative on day 29
    • Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed
  • SR-low by age and WBC
    • No unfavorable features
    • RER by day 15
    • MRD negative on day 29
    • CNS1
    • Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation
  • SR-high
    • Unfavorable features meeting ≥ 1 of the following criteria:
    • MLL rearrangements and RER
    • Steroid pretreatment
    • CNS3
    • Slow early responder by morphology or MRD
• Patients with Down syndrome are allowed
• Concurrently enrolled on COG-AALL03B1
• Age: 1 to under 10
• No prior cytotoxic chemotherapy except intrathecal cytarabine
• Prior steroid therapy allowed per investigator discretion
• No contraindication to additional asparaginase therapy after induction for the standard risk-low study
• No concurrent intensity-modulated radiotherapy

Trial Sponsor

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

Project Begin Date

• Jul 2005

Tentative Project End Date

• Sept 2009

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Revised March 31, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .