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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06973668
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 22, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 01A:Treatment With Post-Transplant Cyclophosphamide (PTCy), Sirolimus and MMF
    15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily
  • Experimental: 01B:Treatment With Post-Transplant Cyclophosphamide (PTCy),Sirolimus and Ruxolitinib
    5 mg PO every 12 hours

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Uday Popat, MBA,MD
[email protected]
713-563-0812
Uday Popat, MBA,MD (PRINCIPAL_INVESTIGATOR)

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