Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism
- Determine the effect of irradiated donor T-cell infusion on donor T-cell chimerism 6
weeks after hematopoietic stem cell transplantation in patients with hematologic
- Determine the infusional toxic effects of irradiated donor lymphocytes in these
- Determine the risk of acute and chronic graft-versus-host disease from donor lymphocyte
infusions on day 45 and day 100 posttransplantation in HLA 6/6 matched transplantations
from a related donor in these patients.
- Determine disease-free survival, cytomegalovirus reactivation, and relapse in patients
treated with this regimen.
- Determine transplant-related mortality and death from all causes in patients treated
with this regimen.
- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4
and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo total body
irradiation on days -7 to -4.
- Pretransplantation irradiated donor lymphocyte infusion (DLI): Patients receive
irradiated DLI on day -4.
- Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day
- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days
- Posttransplantation DLI: Patients receive DLI on days 45 and 100. Patients with chronic
myelogenous leukemia in chronic phase who are polymerase chain reaction negative for
bcr/abl receive DLI on day 45 only.
Patients are followed at 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Austin J. Barrett, MD, FRCP
NHLBI - Bone Marrow Transplantation Unit
United States: Federal Government
|Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892-1182|