DEC-C Post-Transplant

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

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 1/2
Enrollment
126
Last Updated
3 months ago
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Participating Centers

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Experimental Treatments

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  • Inqovi is an oral chemotherapy medication. It combines two different drugs, decitabine, which is a hypomethylating chemotherapy agent, and cedazuridine, which is a CDA inhibitor that helps decitabine to work effectively in the body.

Arms / Cohorts

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Accepting patients

Phase 1 Dose Level 1: DEC-C

Accepting patients

Phase 1 Dose Level 2: DEC-C

Accepting patients

Phase 2 MRD Positive: DEC-C

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