Last updated on February 2012

Fludarabine Busulfan and Alemtuzumab Followed By Donor Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disease


Brief description of study

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before transplant and tacrolimus before and after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving fludarabine and busulfan together with alemtuzumab followed by donor stem cell transplant and to see how well it works in treating patients with hematological cancer or other disease.

Detailed Study Description

OBJECTIVES: - To assess the safety and feasibility of reduced-intensity preparative regimen comprising fludarabine, busulfan, and alemtuzumab followed by allogeneic hematopoietic stem cell transplantation in patients with hematological malignancies or other diseases. - To assess the rate of donor engraftment in patients treated with this regimen. OUTLINE: This is a multicenter study. - Reduced-intensity preparative regimen: Patients receive busulfan IV over 3 hours on days -5 and -4, fludarabine IV on days -5 to -2, and alemtuzumab IV on days -6 to -4. - Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously over 24 hours or orally every 12 hours beginning on day -2 and continuing until day 30, followed by a taper. After completion of study treatment, patients are followed periodically.

Clinical Study Identifier: NCT00625144

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