drugset / Trial / NCT06612944

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

NCT06612944 ↗

NaSingle-groupOpen-labelPrevention

Summary

By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells \> 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.

Timeline

Start
2024-11-12
Primary completion
2027-11-12
Completion
2028-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 32 mg/m2 Subcutaneous
Subject Decitabine Small molecule 5 mg/m2 Subcutaneous
Subject VEN Unknown 100 mg Oral
Subject VEN Unknown 400 mg Oral