RIC Regimen for Low- and Intermediate-risk MDS Receiving Haplo-HSCT
Summary
This study aimed to evaluate the efficacy of reduced intensity conditioning (RIC) regimen in low- and intermediate-risk myelodysplastic syndrome (MDS) patients who receive haploidentical hematopoietic stem cell transplantation (haplo-HSCT). Haplo-HSCT is an effective treatment option for MDS patients who did not have identical sibling donor (ISD) or unrelated donor (URD). However, post-transplant transplant-related mortality (TRM) is one of the major causes for transplant failure in MDS patients, and the risk of TRM for haplo-HSCT recipients was higher than that of ISD recipients. RIC regimen can decrease the risk of TRM for haplo-HSCT recipients; however, the risk for relapse may increase in these patients. Thus, RIC regimen may be more appropriate for low- and intermediate-risk MDS patients receiving haplo-HSCT. The study hypothesis: Using RIC haplo-HSCT regimen in patients with low- and risk MDS can reduce TRM and improve survival.
Timeline
- Start
- 2018-02-01
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2.5 mg/kg | — |
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |
| Subject | Semustine | Small molecule | 250 mg/m2 | — |