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NCT04742634 · ClinicalTrials.gov registry record · Phase 1
Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant
A Phase 1 study of Myelodysplastic Syndromes, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 209
- Enrollment target
- 1
- Study location
NCT04742634 is a Phase 1 study of Myelodysplastic Syndromes that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 209 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04742634, a Phase 1 study of Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 209 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG DEC-C
- DEVICE MyeloSeq-HD
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2033-11-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04742634
The ClinicalTrials.gov registry entry for NCT04742634 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 209 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (26% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which DEC-C is the first listed.
NCT04742634 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04742634 about?
NCT04742634 is a clinical study titled "Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant". 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 molecula...
What is the current status of trial NCT04742634?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 209 participants. The study started on 2022-05-12. Estimated completion is 2033-11-30.
What conditions does trial NCT04742634 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes.
What interventions are being tested in trial NCT04742634?
The interventions under investigation include: DEC-C (DRUG), MyeloSeq-HD (DEVICE).
Who is sponsoring clinical trial NCT04742634?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04742634 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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