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Investigator(s):
Kirsten M. Williams, M.D Phone: 301-435-6456 Fax: 301-480-4354 williaki@mail.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Sheila Phang, R.N., M.S. Phone: 301-435-9379 Fax: 301-451-5578 sphang@mail.nih.gov

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Key Eligibility Criteria:

• ≥ 15 (≥ 9 in those who are ≥ Tanner Stage 2) and ≤ 40 years of age
• Diagnosis of a hematologic malignancy for which bone marrow transplant (also called stem cell transplant) is standard of care (acute myelogenous leukemia, acute lymphocytic leukemia, or high-risk myelodysplastic syndrome)
• Eligible for an allogeneic bone marrow transplant (BMT)—from a donor
• Has an HLA-matched related donor, excluding identical twins (matched at least 7 loci out of 8 at the allele or antigen level, excluding antigen DRB1 mismatch) or unrelated donor matched at HLA-A, B, C, and DR loci by high resolution typing (8/8 antigen/allele match)*
• Karnofsky or Lansky performance status ≥ 60 percent
• No prior allogeneic BMT
• Adequate organ function
• No clinically significant intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

* If an HLA-matched donor has not been found, the NCI study team will perform a search to identify a match.

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Study Outline:

• Screening with a physical examination, medical history, blood and urine tests, and imaging studies
• Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first
• All females and half of the males will receive a shot of lupron 2 weeks prior to the bone marrow transplant (BMT)
• BMT preparative regimen of total body irradiation and chemotherapy using cyclophosphamide (to kill the recipient’s unhealthy bone marrow cells)
• BMT using the healthy donor cells
• Graft-versus-host disease (GVHD) prophylaxis using methotrexate and tacrolimus
• Patients > 18 years of age may also undergo an FLT nuclear medicine imaging test
• Follow-up visits

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 2/21/12