Sirolimus+Ruxolitinib+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to CNI

Sponsor
Peking University People's Hospital
Study ID
NCT07796620
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Leukemia
  • Myelodysplastic Syndromes
  • Severe Aplastic Anemia (SAA)

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sirolimus — DRUG
    Sirolimus 2mg once daily, maintaining the concentration at 5-10 ng/ml. Gradually reduce the dosage after +100 days. If the patient has stable engraftment and no GVHD, discontinue on +180 days.
  • Ruxolitinib — DRUG
    Ruxolitinib is administered at a dose of 5mg twice daily from the start of the study until +90 days. The dose is reduced to 5mg once daily on +90 days, and discontinued on +120 days.
  • MMF — DRUG
    MMF 0.5g, taken twice daily, is discontinued after 60 days. If it is resumed after 60 days, it should be taken for 2 weeks.
  • ATG — DRUG
    2.5 mg/kg, from -5d to -2d

Study Details

Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Ruxolitinib and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.

Key Dates

First listed
Sep 1, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Sirolimus+Ruxolitinib+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG)
    Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Ruxolitinib+MMF+ATG (SRMA) for prophylaxis of aGVHD

Primary Outcome Measure

Incidence of Grade 2-4 aGVHD within 100 days post transplantation [ Time Frame: Participants will be followed for an expected average of 100 days post transplantation ]

Central Contacts

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