Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors
- Determine a standard approach to hematopoietic stem cell transplantation with matched
unrelated donors in patients with hematologic malignancies.
- Determine the toxicity of this regimen in these patients.
- Determine the relapse rate and survival rate in patients treated with this regimen.
- Correlate incidence and severity of graft-versus-host disease with relapse and survival
in patients treated with this regimen.
OUTLINE: Patients receive 1 of the following preparative regimens:
- Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and
cyclophosphamide IV over 2 hours on days -6 and -5. Patients also undergo total body
irradiation (TBI) twice daily on days -4 to -1.
- Regimen B: Patients receive cyclophosphamide IV and TBI as in regimen A.
- Regimen B2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4.
Patients also undergo TBI twice daily on days -3 to -1.
- Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and
cyclophosphamide IV over 2 hours on days -4 to -2.
All patients undergo stem cell transplantation from a matched, unrelated donor on day 0.
Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5
PROJECTED ACCRUAL: 50
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rates of durable engraftment
at day 42
Kenneth Cooke, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|