Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help prevent a serious condition called graft-versus-host disease (GVHD) in patients undergoing a specific type of stem cell transplant known as haploidentical hematopoietic stem cell transplantation (haplo-HSCT). This type of transplant can be a treatment option for conditions like myelodysplastic syndrome and acute leukemia. The researchers want to see if combining two existing treatments—one that uses a medication called ATG and another called post-transplant cyclophosphamide (PTCy)—can improve outcomes for patients by lowering the risk of infections and disease relapse.

To be eligible for this trial, participants need to be between the ages of 12 and 65 and must be receiving a haploidentical stem cell transplant for the first time. They should have a good performance status, meaning they can carry out daily activities, and their heart and kidney function must meet certain health criteria. However, individuals with severe organ dysfunction, active infections, or other serious health issues won’t be eligible. If you or a loved one qualifies and decides to participate, you will be closely monitored throughout the trial to assess how well the new treatment works and to ensure your safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with AL - CR and/or myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation for the first time;
• • 2. No gender limit, aged 12 - 65 years;
• • 3. Planned haploidentical donor transplantation, excluding transplantation from maternal and collateral donors;
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status score≤3 points;
• 5. Baseline organ function tests meet the following criteria:
• • (1) Left ventricular ejection fraction (LVEF) \> 55%; (2) Serum creatinine ≤ 1.5 × upper limit of normal (ULN).
• Exclusion Criteria:
• • 1. Patients with severe dysfunction of brain, heart, kidney or liver;
• • 2. Those in refractory malignant status;
• • 3. Patients with other malignancies requiring treatment;
• • 4. Presence of uncontrolled severe active infection clinically;
• • 5. Expected survival period of less than 3 months;
• • 6. History of severe allergic reactions;
• • 7. Pregnant or breastfeeding women; (8)Presence of any condition deemed by the investigator as unsuitable for study enrollment.