A Phase I/II Trial of Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
Washington University School of Medicine
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
This study uses a two-stage eligibility process. Step 1 assesses eligibility prior to the MyeloSeq-HD assay being performed, while Step 2 assesses eligibility of MRD-positive patients for the intervention arm and MRD-negative patients for the observation arm. Patients who are MRD-positive who are determined to be ineligible to continue into the intervention arm must satisfy the eligibility criteria for the observation arm in order to be enrolled in that arm. Eligibility Criteria for MyeloSeq-HD Assay (Step 1) * Diagnosis of myelodysplastic syndromes (MDS) based on World Health Organization c…
Interventions
- DrugDEC-C
* DEC-C will be provided by Taiho Pharmaceuticals. * Cycle 1 Day 1 may take place between Day 42 \& Day 100 post-transplant.
- DeviceMyeloSeq-HD
-Laboratory test developed at Washington University School of Medicine
Location
- Washington University School of MedicineSt Louis, Missouri