Drug Combinations for Acute Graft-versus-Host Disease

Overseen By Uday Popat, MBA,MD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: HIV, Acute promyelocytic leukemia, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Uday Popat, MBA,MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for people aged 65-75 with Acute Myeloid Leukemia or related conditions, who have a suitable stem cell donor. They must be in good health with proper organ function and agree to use contraception. It's not for those with HIV, high-risk comorbidities, pregnancy, certain leukemia types, uncontrolled diseases like infections or heart issues.

Inclusion Criteria

Voluntary signing of an informed consent

Agreement to use adequate contraception for women of child-bearing potential and men throughout the study period

My liver, kidneys, lungs, and heart are functioning well.

Exclusion Criteria

Positive for HIV

Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of >5

Pregnancy or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive post-transplant cyclophosphamide, sirolimus, and either MMF or ruxolitinib to prevent GVHD

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Cyclophosphamide
• Mycophenolate Mofetil
• Ruxolitinib
• Sirolimus

Trial Overview The study compares two drug combinations after a stem cell transplant: cyclophosphamide with sirolimus and either MMF (Mycophenolate Mofetil) or ruxolitinib. The aim is to see which combo better prevents Graft Versus Host Disease (GVHD), a common post-transplant complication.

Participant Groups

Group I: 01B:Treatment With Post-Transplant Cyclophosphamide (PTCy),Sirolimus and Ruxolitinib Experimental Treatment 1 Intervention

5 mg PO every 12 hours

Group II: 01A:Treatment With Post-Transplant Cyclophosphamide (PTCy), Sirolimus and MMF Experimental Treatment 1 Intervention

15 mg/kg/dose (max: 1,000mg/dose) IV/PO three times daily

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+