PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation
NCT05120570 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-12-22
Summary
This is a single-arm, phase I/II, study of PTCy/sirolimus plus VIC-1911 to prevent GVHD and relapse after Allogeneic Hematopoietic Cell Transplantation (alloHCT).
Conditions
- Acute Leukemia
- Myelodysplastic Syndromes
- Myeloproliferative Neoplasm
- Lymphoma
Interventions
- DRUG
-
VIC- 1911
25 mg, 50 mg, or 75 mg administered twice a day from day 5 post HCT to day 45, and the dose escalation will stop once we identify the lowest biologically active and safe dose of VIC.
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Sherman Holtan, MD · Masonic Cancer Center, University of Minnesota
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-17
- Primary Completion
- 2024-09-19
- Completion
- 2025-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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