A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
- To estimate the incidence of graft rejection and severe graft-versus-host disease after
myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from
first-degree relatives in patients with high-risk hematologic malignancies.
- To estimate overall survival, relapse, non-relapse mortality, and event-free survival
in these patients.
- To characterize additional hematologic and non-hematologic toxicities of myeloablative
- To characterize donor hematopoietic chimerism in peripheral blood stem cells after
- Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days
-7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2
hours on days -3 and -2.
- Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo
infusion of unmanipulated peripheral blood stem cells on day 0.
- Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours
on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and
oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90.
Treatment continues in the absence of disease progression or clinically significant
After completion of PBSCT, patients are followed periodically for 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Graft Rejection for Patients at Day 100
Number of patients who experienced graft rejection by Day 100
Scott R. Solomon, MD
Blood and Marrow Transplant Group of Georgia
United States: Food and Drug Administration
|Blood and Marrow Transplant Group of Georgia||Atlanta, Georgia 30342-1601|