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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06279494
Other study ID # Sirolimus for GVHD prophylaxis
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 2024
Est. completion date March 2025

Study information

Verified date March 2024
Source Peking University People's Hospital
Contact Yuqian Sun, M.D.
Phone +86-10-88324577
Email sunyuqian83@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6
Est. completion date March 2025
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility Inclusion criteria: 1. Primary disease: hematological malignancies (including acute leukemia, myelodysplastic syndromes), nonmalignant disorders (including severe aplastic anaemia) 2. Contraindication or intolerance to CNI 1. Glomerular filtration rate (GFR) 60-89 ml/min/1.73m2 before transplantation or allergy to CNI 2. Intolerance to CNI during conditioning or within +45 days post transplantation, such as CNI nephrotoxicity (creatinine higher than the upper limit of normal), uncontrolled hypertension, neurological toxicity, or other conditions deemed by physician to be inappropriate for CNI 3. Receiving haplo-HSCT for the first time Exclusion Criteria: 1. Allergy or intolerance to study drugs 2. Active infection 3. Active GVHD 4. Transplantation-associated thrombotic microangiopathy 5. Key organ dysfunction: liver injury (total bilirubin more than 2 upper limit of normal) or heart injury (symptomatic heart failure or ejection fraction<50%) 6. Eastern Cooperative Oncology Group (ECOG) score >2 7. Expected survival time <30 days 8. Patients could not cooperate

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Cumulative incidence of relapse Participants will be followed for an expected average of 1 year
Other Transplant-related mortality Participants will be followed for an expected average of 1 year
Other Overall survival Participants will be followed for an expected average of 1 year
Other Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) Participants will be followed for an expected average of 1 year
Primary 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 Incidence of chronic GVHD (cGVHD) within 1 year post transplantation Participants will be followed for an expected average of 1 year
Secondary Incidence of thrombotic microangiopathy within 1 year post transplantation Participants will be followed for an expected average of 1 year
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