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
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.
Interventional
Primary Purpose: Treatment
Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
No
Ann E. Woolfrey, MD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration
1981.00
NCT00555048
September 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |