NCT06279494

Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors

Sirolimus+Abatacept+Mycophenolate Mofetil Regimen for Prophylaxis of Acute Graft-versus-host Disease (aGvHD) in Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation (Haplo-HSCT) Who Are Intolerant to Calcineurin Inhibitor

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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 tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors.

Conditions

• Acute Leukemia
• Myelodysplastic Syndromes
• Severe Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Sirolimus	Orally (concentration 5-10ng/ml) from -1 to +100d post haplo-HSCT
DRUG	Abatacept	5mg/kg subcutaneous, -1/+5/+14/+28/+42/+56d post haplo-HSCT
DRUG	MMF	0.5g bid orally, from -3d to +60d post haplo-HSCT
DRUG	ATG	2.5 mg/kg, from -5d to -2d

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-06-01
• Completion: 2025-03-01
• First posted: 2024-02-28
• Last updated: 2024-03-21