AALL0932: This phase III trial is evaluating different combinations of chemotherapy for the treatment of children who have Lymphoblastic Leukaemia or Lymphoblastic LymphomaTreatment of Patients With Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) (Other ID's: CDR0000683227, COG-AALL0932)

Exclusion

• With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932

  • Patients receiving prior steroid therapy may be eligible for AALL0932

• Patients with central nervous system 3 (CNS3) leukemia

  • CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
• B-ALL patients with testicular leukemia are not eligible for AALL0932

• For B-LLy patients the following additional exclusion criteria apply:

  • T-lymphoblastic lymphoma
  • Morphologically unclassifiable lymphoma
  • Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
  • CNS3-positive disease or testicular involvement
  • M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
  • Female patients who are pregnant are ineligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation