drugset / Trial / NCT01203722

Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies

NCT01203722

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-09
Primary completion
2024-05-28
Completion
2024-05-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sirolimus Small molecule 2 mg Oral
Comparator Tacrolimus Small molecule 1 mg Intravenous
Comparator Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Comparator Fludarabine Small molecule 30 mg/m2 Intravenous
Comparator Mycophenolate Mofetil Small molecule 15 mg/kg Oral