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Investigator(s):
Michael R. Bishop, M.D. Principal Investigator Phone: 301-435-2764 Fax: 301-451-5578 mbishop@mail.nih.gov	Rachel Salit, M.D. Lead Associate Investigator Phone: 301-435-5391 salitr@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	Caroline Stewart, R.N., B.S.N. Transplant Coordinator Phone: 301-451-6569 Fax: 301-451-5578 cstewartv@mail.nih.gov

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Primary Eligibility:

• Age 18–69 years
• Diagnosis of an advanced or high-risk hematologic malignancy, including Hodgkin lymphoma, non-Hodgkin lymphoma, chronic myelogenous leukemia, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, multiple myeloma, myelodysplastic syndrome or myeloproliferative disorders
• No available HLA-matched sibling or ≥ 7/8 HLA-matched unrelated donor
• Life expectancy of at least 3 months
• ECOG ≤ 2
• Relatively normal major organ function
• Patients must have two partially HLA-matched UCB units
• Units must be HLA matched at HLA-A and B (intermediate resolution molecular typing) and DRB1 (high resolution molecular typing) 4-6/6 with the recipient and 4-6/6 with each other
• Each unit must contain a minimum pre-cryopreserved, nucleated cell dose of 1.5 x 10⁷ per kg

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Study Outline:

This is a pilot study of TID in the setting of reduced-intensity double cord blood transplant in adults.

• All patients will receive:
• Disease-specific induction chemotherapy (EPOCH-F/R or FLAG) prior to transplant for disease control and immune depletion
• A conditioning regimen consisting of cyclophosphamide 1,200 mg/m²/day IV for 4 days and fludarabine 30 mg/m²/day for 4 days
• GVHD prophylaxis regimen consisting of tacrolimus, starting day -3 before transplant, given initially at 0.02 mg/kg/day CIV and then an equivalent oral dose for 6 months, and sirolimus given as an initial loading dose of 12 mg p.o. on Day -3 pretransplant and subsequently 4 mg daily through 6 months post transplant

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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.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 10/7/09