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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: Recruiting Phase 1 study of Myelodysplastic Syndromes, sponsored by Washington University School of Medicine.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

-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 requir

Conditions Studied

Interventions

  • DRUG DEC-C
  • DEVICE MyeloSeq-HD

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 209 participants
Start Date 2022-05-12
Est. Completion 2033-11-30
Phase Phase 1

What NCT04742634 shows while recruiting

NCT04742634 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (26% lower).

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 a single indexed study location in 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.

Similar trials for Myelodysplastic Syndromes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04742634's enrollment target sits among peer trials

209 32nd of 173 higher than 142 of 173 other Myelodysplastic Syndromes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04742634, the US trial registry maintained by the National Library of Medicine. NCT04742634 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.