A Two Step Approach To Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies From HLA Partially-Matched Related Donors
Haploidentical hematopoietic stem cell transplant is a life-saving therapy for patients who
are without well matched donors. This type of therapy has been associated with poor
outcomes in the past due to complications such as infection. The Jefferson 2 Step approach
was designed to allow the infusion of an exact dose of tolerized lymphocytes in
haploidentical transplant in order to allow for immune reconstitution post transplant to
avoid infectious complications while still having acceptable rates of GVHD. In this
approach, patients with high-risk hematological malignancies undergo 8 fractions of TBI (12
Gy) followed by an exact dose of donor lymphocytes. The phase I portion of the study
determined the optimal dose of lymphocytes. Two days after receiving the donor lymphocytes,
the patients receive 2 daily doses of cyclophosphamide. One day after receiving
cyclophosphamide, the patients receive stem cell from their donor. Tacrolimus and
mycophenylate mofetil are used as GVHD prophylaxis.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Survival of Participants
To determine overall survival at 6 months post-transplant.
6 months
No
Neal Flomenberg, MD
Principal Investigator
Thomas Jefferson University
United States: Institutional Review Board
06U.20
NCT00429143
January 2006
June 2010
Name | Location |
---|---|
Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |