DEC-C for Myelodysplastic Syndromes (MDS) After Transplant
This study is testing a treatment called DEC-C (decitabine + cedazaridine) for people with Myelodysplastic Syndromes (MDS) who have had a stem cell transplant. The goal is to see if giving DEC-C early, when small amounts of cancer cells (measurable residual disease or MRD) are still present, can stop the disease from getting worse. Researchers will use a special test called MyeloSeq-HD to find these remaining cancer cells. If you are between 18 and 75 years old and have MDS after a transplant, you might be able to join. The study will look at how safe DEC-C is and what dose works best. The current status of the study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 209 participants. It includes a Phase I part to determine the maximum tolerated dose and recommended Phase II dose.
- What's involved
- DEC-C treatment may begin between 42 and 100 days after your transplant. The primary endpoints for Phase I are measured at the completion of cycle 1 (each cycle is 28 days), estimated to be 13 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for Phase I are measured at the completion of cycle 1 (each cycle is 28 days), estimated to be 13 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Meagan Jacoby, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of patients with dose-limiting toxicities (Phase I only)Completion of cycle 1 (each cycle is 28 days) for all phase I participants (estimated to be 13 months)
-Dose-limiting toxicities (DLTs) are defined as any of the following adverse events that occur during the DLT observation period (Cycle 1) during the phase I portion of the study, determined to be possibly, probably, or definitely related to the study drug: * Grade 4 neutropenia or grade 4 thrombocytopenia in the absence of increased blasts and/or evidence of persistent MDS at the end of Cycle 1. * Any grade 3 or higher non-hematologic toxicity except for grade 3 vomiting or diarrhea not requiring tube feeding, total parenteral nutrition, or requiring or prolonging hospitalization, or grade 3 or 4 isolated electrolyte abnormalities that last \<72 hours. * Any other non-hematologic toxicity that is clinically significant and/or unacceptable that does not respond to supportive care, results in disruption of dosing schedule more than 28 days, or is judged to be a DLT by the Investigator. * Confirmed Hy's law cases will be considered a DLT
- Maximum tolerated dose (MTD) (Phase I only)Completion of cycle 1 (each cycle is 28 days) for all phase I participants (estimated to be 13 months)
-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which ≥ 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle.
- Recommended phase II dose (Phase I only)Completion of cycle 1 (each cycle is 28 days) for all phase I participants (estimated to be 13 months)
-The recommended phase II dose will be less than or equal to the maximum tolerated dose
- Progression-free survival (PFS) (Phase II recommended dose only)1 year post-transplant
-Progression-free survival: Defined as the interval from the date of transplant to disease progression or death, whichever is first. Patients without documented disease progression or death at the time of analysis will be censored at the date of last adequate tumor assessment.
- Rate of relapse (Phase II recommended dose only)1 year post-transplant
-Disease progression/relapse post-transplant is defined as \>5% myeloblasts in the bone marrow, evidence of extramedullary disease, reemergence of pre-transplant cytogenetic abnormalities, or intervention by the treating physician (such as withdrawal of immunosuppression) for reemergence of pre-transplantation morphologic abnormalities that are likely relapsed disease in the opinion of the treating physician. Censoring rules for the Relapse endpoint include: Patients who do not relapse will be censored at the date of last disease assessment where no relapse was documented; Patients who die without relapse will be censored at the date of death if no relapse was observed prior to death. Patients who withdraw consent or are lost to follow-up will be censored at the date of last disease assessment showing no evidence of relapse; Patients who start a new anti-cancer therapy before documented relapse will be censored at the date of last disease assessment before the start of the new therapy.