Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

Inclusion Criteria:

• Ages 0-21

• AML in one of the following stages:

  • Having preceding myelodysplasia (MDS)
  • High Risk cytogenetics
  • Requiring > 2 cycles chemotherpay to obtain complete remission
  • Second of greater CR
  • First relapse with < 25% blasts in bone marrow
  • With therapy-related AML whose prior malignancy has been in remission for at least 12 months

• ALL in one of the following stages:

  • High Risk First remission as defined as either Philadelphia + ALL or MLL rearrangement with slow early response, or hypodilpoidy, or end of induction M3 bone marrow, or end of induction M2 with M2-3 at Day 41.
  • High Risk Second remission as defined as either bone marrow relapse < 36 months from induction, or T-lineage relapse at any time, or very early isolated CNS relapse or slow induction after relapse at any time
  • Any third of subsequent CR
• Biphenotypic or undifferentiated leukemia in any CR or if in first relapse must have < 25% blasts in bone marrow
• MDS at any stage; prior therapies allowed
• CML in chronic or accelerated phase; prior therapies allowed

• Patient also must have the following organ requirements:

  • Adequate renal function defined as serum creatinine <2x normal, or creatinine clearance > 40 ml/min/m^2 or 70 ml/min.
  • Adequate liver function as defined by total bilirubin less than or equal to 2 times normal and AST and ALT less than or equal to 4 times normal.
  • Adequate cardiac function as defined by: shortening fraction > 24% by echocardioagram, or ejection fraction > 30% by radionucline angiogram.
  • Adequate pulmonary function as defined by DLCO, FEV1/FVC > 60% by pulmonary function tests. For children who are uncooperative for PFTs ans have no evidence of dyspnea at rest of ecercise intolerance, pulse oximetry > 94% on room air is considered acceptable, with a normal chest xray.
  • Adequate venous access; a double lumen central vascular access device or its equivalent and an additional PICC line will be required for all patients.
• Women of childbearing potential and sexually active males should use effective contraception while on study.

Exclusion Criteria:

• Inability to give informed consent or assent
• Inability to obtain a suitable donor
• Patient who is HIV-positive
• Patient who has active Hepatitis B
• Patient who is pregnant
• Patient who is otherwise considered unsuitable for transplant at the discretion of the principal investigator.