drugset / Trial / NCT05895201
High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD
NaSequentialOpen-labelTreatment
Summary
This is an open label Phase I-II study to determine the safe doses of bortezomib, sitagliptin, and PTCy (Phase I) with expansion into a phase II trial to determine efficacy in improving survival.
Timeline
- Start
- 2023-11
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Subject | Sitagliptin | Small molecule | 400 mg | Oral |
| Subject | Sitagliptin | Small molecule | 600 mg | Oral |