Leukemia Clinical Trial
Official title:
A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill
them or deliver cancer-killing substances to them without harming normal cells. Giving
chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell
transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor
are infused into the patient they may help the patient's bone marrow make stem cells, red
blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor
can make an immune response against the body's normal cells. Giving tacrolimus and
methotrexate after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together
with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how
well it works in treating patients with hematologic cancer.
OBJECTIVES:
Primary
- Identify the lowest dose of alemtuzumab that is associated with day 180
transplant-related mortality ≤ 45%.
Secondary
- Determine the incidence of life-threatening infection in patients receiving this
treatment.
- Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients
receiving this treatment.
- Determine the survival at 1 year in patients receiving this treatment.
- Determine the incidence of disease relapse at 1 year in patients receiving this
treatment.
- Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this
treatment.
- Determine the incidence of graft failure at day 100 in patients receiving this
treatment.
OUTLINE:
- Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan
IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2.
- Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic
filgrastim (G-CSF)-mobilized PBSC transplantation on day 0.
- Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or
orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically.
;
Primary Purpose: Treatment
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