Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Inclusion Criteria:

   - Patient has newly diagnosed acute leukemia:

      - > 25% blasts on a bone marrow (BM) aspirate or

      - If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the
      diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM
      biopsy or

      - A complete blood count (CBC) documenting the presence of at least 1,000/uL
      circulating leukemic blasts

   - Adequate samples must be provided to the reference and/or COG-approved cytogenetics
   laboratories to allow completion of the studies needed for risk-stratification

      - If a BM aspirate is not performed, or adequate material cannot be obtained,
      peripheral blood (PB) can be substituted for BM if there are at least 1,000
      circulating blasts/uL (i.e., a white blood cell [WBC] count of 10,000/uL with 10%
      blasts or a WBC count of 5,000/uL with 20% blasts); if only PB is submitted,
      please obtain and send twice the volume of PB as the recommended BM volume
      specified; the patient will remain on AALL08B1 as long as all required central
      laboratory tests can be successfully performed; as long as there are at least
      1,000/uL PB blasts, institutions are encouraged to submit PB in addition to BM
      samples to make sure that adequate material is available to perform the required
      studies

      - If an adequate BM aspirate cannot be obtained and there are fewer than 1,000/uL
      PB blasts, the patient is not eligible for AALL08B1 or a frontline COG ALL
      clinical trial (there are NO exceptions to this rule)

   - Patient has suspected ALL:

      - Patients whose blast morphology is obviously myeloid, or whose blasts are
      myeloperoxidase positive, should not be enrolled on AALL08B1; however, patients
      with true biphenotypic or bilineage leukemia (i.e., patient presents with blasts
      with significant expression of multiple lymphoid and myeloid markers such that
      assignment to a single lineage is not possible) are eligible to enroll in
      AALL08B1 for cell banking

   - Samples must be sent to a COG-approved cytogenetics laboratory, and COG Reference
   Laboratory studies; if informative results needed for treatment stratification are not
   available at specified time-points during induction, patients will not be eligible to
   receive post-induction therapy on a COG ALL trial

   - All patients and/or their parents or legal guardians must sign a written informed
   consent

   - All institutional, Food and Drug Administration (FDA) and National Cancer Institute
   (NCI) requirements for human studies must be met

Exclusion Criteria:

   - Patient must not have received prior cytotoxic therapy except for steroids or
   intrathecal chemotherapy

   - Patient must not have secondary ALL that developed after treatment of a prior
   malignancy with cytotoxic chemotherapy