A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
NCT06973668 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-05-20
Summary
The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.
Conditions
Interventions
- DRUG
-
Mycophenolate Mofetil
15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily
- DRUG
-
5 mg PO every 12 hours
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Uday Popat, MBA,MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-22
- Primary Completion
- 2028-01-31
- Completion
- 2030-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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