A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders
- To evaluate hematopoietic recovery, using neutrophil and platelet engraftment as the
primary criterion, in patients with advanced hematologic malignancies or other
disorders undergoing allogeneic peripheral blood stem cell (PBSC) transplantation from
matched unrelated donors.
- To evaluate the incidence of acute and chronic graft-versus-host-disease (GVHD) in
patients undergoing allogeneic PBSC transplantation from matched unrelated donors.
- To evaluate the impact of HLA class I and class II allele-matching on the incidence of
GVHD and on the survival outcome of these patients.
- To evaluate overall survival, disease-free survival, and relapse in these patients.
OUTLINE: Patients are stratified according to type of conditioning regimen (myeloablative vs
reduced-intensity myeloablative). Patients are assigned to a conditioning regimen according
to diagnosis, age, disease status, prior radiotherapy, and prior autologous stem cell
- Conditioning regimen:
- Regimen I: Patients undergo total body irradiation (TBI) on days -7 to -4 and
receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive
cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
- Regimen II: Patients receive busulfan IV over 2 hours once on day -8 and then
every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days
-3 and -2.
- Regimen III: Patients undergo TBI on days -7 to -4 and receive etoposide IV on day
- Regimen IV: Patients receive fludarabine phosphate IV over 30 minutes on days -7
to -3 and melphalan IV on day -2.
- Regimen V: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to
-2 and undergo TBI on day 0.
- Regimen VI: Patients receive busulfan IV over 3 hours and fludarabine phosphate IV
over 30 minutes on days -5 to -2.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: All patients undergo
allogeneic PBSC transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive one of the following
GVHD prophylaxis regimens:
- Regimen A: Patients receive tacrolimus IV or orally on days -1 to 180 and
methotrexate IV on days 1, 3, 6, and 11.
- Regimen B: Patients receive cyclosporine IV or orally twice daily on days -1 to
180, mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-27, and
methotrexate IV on days 1, 3, and 6.
- Regimen C: Patients receive tacrolimus IV continuously or orally, and oral
sirolimus beginning on day -3. Patients also receive methotrexate IV on days 1, 3,
After completion of study therapy, patients are followed periodically.
Masking: Open Label, Primary Purpose: Treatment
Neutrophil and platelet engraftment
Auayporn P. Nademanee, MD
Beckman Research Institute
United States: Federal Government