Interfant 06: This trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemiaInternational collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukaemia (Other IDs: CDR0000570260, DCOG-INTERFANT-06, EudraCT 2005-004599-19, CCLG-LK-2006-10).

Inclusion

• Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria:

  • Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
  • Newly diagnosed disease

  • Verified by morphology and confirmed by cytochemistry and immunophenotyping

    • Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap"

• Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria:

  • Low-risk disease, defined as all MLL germline cases

  • Medium-risk disease, defined by 1 of the following criteria:

    • MLL status unknown
    • MLL rearranged AND age > 6 months
    • MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response

  • High-risk disease, defined by MLL rearrangement AND meets the following criteria:

    • Age at diagnosis < 6 months (i.e., < 183 days)
    • WBC ≥ 300 x 10^9/L AND/OR prednisone poor response

• Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation:

  • Donor meeting 1 of the following criteria:

    • HLA-identical sibling
    • Very well-matched related or unrelated donor
    • Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping

  • Stem cell source

    • Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim [G-CSF]-stimulated donors OR cord blood

      • Highly-matched unrelated umbilical cord blood (UCB) (> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., > 1.5 x 10^7/kg recipient body weight [BW]) is cryopreserved
  • Must have ≥ 3 x 10^8 NCs/kg BW OR 3 x 10^6/kg BW CD34-positive cells available for transplantation
• CNS or testicular leukemia at diagnosis allowed