Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
If transplantation using mismatched unrelated donors or non-first-degree relatives could be
performed with an acceptable toxicity profile, an important unmet need would be served.
Towards this goal, the current study extends our platform of nonmyeloablative, partially
HLA-mismatched bone marrow transplant (BMT) and Peripheral Blood Stem Cell Transplant (PBSCT)
to the use of such donors, investigating up to several postgrafting immunosuppression
regimens that incorporate high-dose Cy. Of central interest is the incorporation of sirolimus
into this postgrafting immunosuppression regimen.
The primary goal for phase 1 is to identify a transplant regimen associated with acceptable
rates of severe acute GVHD and NRM by Day 100 and for phase 2 estimate the 6-month
probability of survival without having had acute grade III- IV GVHD or graft failure.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins