Preventing Relapse After Allogeneic Stem Cell Transplant in Very High-Risk MDS Patients Using IPSS-M Risk Grouping A Phase 2 Single-Center Study

What this Trial Is About

Researchers are evaluating a prophylactic intervention to prevent relapse and improve survival rates after allogeneic transplantation in adult patients with very high-risk myelodysplastic syndromes MDS based on IPSS-M stratification. This Phase 2 study aims to assess relapse-free survival at 1 and 2 years post-transplantation by comparing clinical data with historical outcomes. The focus is on reducing disease progression or death following transplantation in this high-risk group. The intervention involves a combination of drugs and cellular therapy. The preferred regimen includes subcutaneous azacitidine injections for 5 consecutive days every 28 days, combined with oral BCL2 inhibitor venetoclax for one week per cycle. For patients with specific mutations or resistance to venetoclax, azacitidine plus decitabine and donor lymphocyte infusion DLI starting 3 months after transplantation are used, with escalating doses of T lymphocytes. This single-arm, prospective study is conducted at a single center. Participants will be monitored for disease relapse and overall survival over 1 and 2 years. Evaluations include clinical assessments of disease progression, organ function tests, and performance status. Researchers will track relapse-free survival as the primary outcome and overall survival as a secondary outcome. The study runs from November 2024 to November 2028, with participants receiving ongoing follow-up to evaluate long-term outcomes and safety.

Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification