drugset / Trial / NCT04742634
Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
Phase 1/2
Recruiting
209 enrolled
Washington University School of Medicine
Taiho Oncology, Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
The investigators hypothesize that early measurable residual disease (MRD)-guided pre-emptive therapy with decitabine + cedazaridine (DEC-C) will decrease the risk of progression in post-transplant myelodysplastic syndromes (MDS) patients with persistent mutations (molecular MRD). To detect molecular MRD, the investigators will perform ultra-deep, error-corrected panel-based sequencing (MyeloSeq-HD) at Day 30 in post-transplant MDS patients. The investigators will treat patients with detectable molecular MRD with DEC-C to determine if pre-emptive, MRD-guided therapy with DEC-C decreases relapse rates and improves progression-free survival.
Timeline
- Start
- 2022-05-12
- Primary completion
- 2033-11-30
- Completion
- 2033-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cedazuridine | Small molecule | 100 mg | Oral |
| Subject | Decitabine | Small molecule | 35 mg | Oral |