Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors
Phase 1
Not yet recruiting
- Conditions
- Interventions
- Registration Number
- NCT06279494
- Lead Sponsor
- Peking University People's Hospital
- Brief Summary
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 tolera...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Not provided
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Exclusion Criteria
- Allergy or intolerance to study drugs
- Active infection
- Active GVHD
- Transplantation-associated thrombotic microangiopathy
- Key organ dysfunction: liver injury (total bilirubin more than 2 upper limit of normal) or heart injury (symptomatic heart failure or ejection fraction<50%)
- Eastern Cooperative Oncology Group (ECOG) score >2
- Expected survival time <30 days
- Patients could not cooperate
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sirolimus+Abatacept+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG) Sirolimus Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Abatacept+MMF+ATG (SAMA) for prophylaxis of aGVHD Sirolimus+Abatacept+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG) MMF Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Abatacept+MMF+ATG (SAMA) for prophylaxis of aGVHD Sirolimus+Abatacept+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG) Abatacept Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Abatacept+MMF+ATG (SAMA) for prophylaxis of aGVHD Sirolimus+Abatacept+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG) ATG Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Abatacept+MMF+ATG (SAMA) for prophylaxis of aGVHD
- Primary Outcome Measures
Name Time Method Incidence of Grade 2-4 aGVHD within 100 days post transplantation Participants will be followed for an expected average of 100 days post transplantation
- Secondary Outcome Measures
Name Time Method Incidence of chronic GVHD (cGVHD) within 1 year post transplantation Participants will be followed for an expected average of 1 year Incidence of thrombotic microangiopathy within 1 year post transplantation Participants will be followed for an expected average of 1 year