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

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Feb 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new combination of medications—Sirolimus, Abatacept, and Mycophenolate Mofetil—to help prevent a complication called graft-versus-host disease (GVHD) in patients who have received a type of stem cell transplant known as haplo-HSCT. GVHD can happen when the donated cells attack the recipient's body, and it occurs in 40-60% of transplant cases. Many patients currently take a medication called calcineurin inhibitors (CNI) to prevent GVHD, but some people can't tolerate these drugs due to side effects. This study aims to see if the new combination is safe and effective for those patients.

To participate in this trial, individuals should have specific blood cancers like acute leukemia or severe aplastic anemia and must not be able to take CNIs due to health reasons or side effects. They should also be receiving their first haplo-HSCT. The trial is not yet recruiting participants, but once it starts, eligible patients will receive the new treatment and be monitored for safety and effectiveness. It's important for potential participants to know that they will not be able to join if they have allergies to the study medications, active infections, or certain other medical conditions.

Gender

ALL

Eligibility criteria

• 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