Ensayos clínicos

Inclusion Criteria:

• B-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0932
• Patients must have newly diagnosed NCI Standard Risk B-ALL or B-LLy Murphy Stages I or II; patients with Down syndrome are also eligible
  • Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
• Meets the criteria for one of the following risk groups after induction therapy
  • Low-risk (LR) disease, defined as meeting the following criteria:
    • Favorable genetics: the presence of simultaneous trisomies of chromosome 4 and 10 (double trisomy; DT) or ETV6/RUNX1 fusion
    • Day 8 peripheral blood (PB) minimal residual disease (MRD) < 0.01%
    • Day 29 bone marrow (BM) MRD < 0.01%
    • No CNS2, CNS3, or testicular leukemia
    • No steroid pretreatment
    • No Down syndrome (DS)
  • Average-risk disease, defined as meeting one of the following sets of criteria:
    • Favorable genetics: the presence of DT or ETV6/RUNX1 fusions
    • Day 8 PB MRD ≥ 0.01% or CNS2 status
    • Day 29 BM MRD < 0.01%
    • No CNS3 or testicular leukemia
    • No DS
    • Neither favorable nor unfavorable cytogenetics
    • Day 8 PB MRD < 1%
    • Day 29 BM MRD < 0.01%
    • No CNS3 or testicular leukemia
    • No DS
  • Standard-risk with Down syndrome (DS), defined as meeting the following criteria:
    • No mixed-lineage leukemia (MLL)-rearrangement, hypodiploidy, or Philadelphia chromosome-positive (Ph+) disease
    • Day 29 BM MRD < 0.01%
    • No CNS3 or testicular leukemia
• WBC count < 50,000/mm^3
• No prior cytotoxic chemotherapy for the current diagnosis of ALL or any cancer diagnosed previously
  • Steroids and intrathecal cytarabine for the current diagnosis of ALL allowed
    • Inhalational steroids are not considered as pretreatment
• Patients with testicular leukemia are not eligible for AALL0932