drugset / Trial / NCT06612944
Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification
Phase 2
Recruiting
40 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |