NCT06973668

A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: To compare Grade 2-4 acute graft versus host disease-free survival (GFS) between the MMF and Ruxolitinib arms Secondary Objectives: To compare the following between treatment arms: 1. Grade 3-5 adverse event of this regimen as per CTCAE v5.0 criteria. 2. Graft versus host disease-free, relapse-free survival (GRFS) 3. Time to neutrophil and platelet engraftment 4. Incidence of acute and chronic GVHD 5. Relapse incidence 6. Non relapse mortality 7. Overall survival 8. Progression-free survival 9. Chimerism 10. Immunosuppression cessation time 11. Rate of graft failure Exploratory Objective: To conduct mechanistic studies to compare immune recovery between arms and correlate these with disease control and GVHD prophylaxis.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily
DRUG	Ruxolitinib	5 mg PO every 12 hours

Timeline

• Start date: 2025-07-22
• Primary completion: 2028-01-31
• Completion: 2030-01-31
• First posted: 2025-05-15
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study