Phase I Study of Sequential Cord Blood Transplants
Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days,
melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD
prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil
starting on day 0. Sequential cord blood units will be infused on Day 0.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
Karen Ballen, M.D.
Massachusetts General Hospital, Harvard University
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|