A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies
OBJECTIVES:
Primary
- 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.
Secondary
- 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
haploidentical PBSCT.
- To characterize donor hematopoietic chimerism in peripheral blood stem cells after
PBSCT.
OUTLINE:
- 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
graft-vs-host disease.
After completion of PBSCT, patients are followed periodically for 1 year.
Interventional
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
Day 100
Yes
Scott R. Solomon, MD
Principal Investigator
Blood and Marrow Transplant Group of Georgia
United States: Food and Drug Administration
CDR0000617648
NCT00782379
October 2008
April 2012
Name | Location |
---|---|
Blood and Marrow Transplant Group of Georgia | Atlanta, Georgia 30342-1601 |