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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Leukemia Myelodysplastic Syndromes Severe Aplastic Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sirolimus+Abatacept+Mycophenolate mofetil (MMF)+anti-thymocyte globulin (ATG)

Patients receiving haplo-HSCT who are intolerant to calcineurin inhibitors would receive Sirolimus+Abatacept+MMF+ATG (SAMA) for prophylaxis of aGVHD

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

Orally (concentration 5-10ng/ml) from -1 to +100d post haplo-HSCT

Abatacept

Intervention Type DRUG

5mg/kg subcutaneous, -1/+5/+14/+28/+42/+56d post haplo-HSCT

MMF

Intervention Type DRUG

0.5g bid orally, from -3d to +60d post haplo-HSCT

ATG

Intervention Type DRUG

2.5 mg/kg, from -5d to -2d

Interventions

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Sirolimus

Orally (concentration 5-10ng/ml) from -1 to +100d post haplo-HSCT

Intervention Type DRUG

Abatacept

5mg/kg subcutaneous, -1/+5/+14/+28/+42/+56d post haplo-HSCT

Intervention Type DRUG

MMF

0.5g bid orally, from -3d to +60d post haplo-HSCT

Intervention Type DRUG

ATG

2.5 mg/kg, from -5d to -2d

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No