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NCT01687400 · ClinicalTrials.gov registry record · Phase 2
Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
A Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 1
- Study location
NCT01687400: Completed Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, sponsored by Washington University School of Medicine.
NCT01687400 is a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute that has completed, run by Washington University School of Medicine. The registered enrollment target is 114 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01687400, a Phase 2 study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a significant proportion of elderly AML patients.
Primary Outcome
-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate --Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)
Conditions Studied
Interventions
- DRUG decitabine
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2013-02-12 |
| Est. Completion | 2017-11-13 |
| Phase | Phase 2 |
What the finished NCT01687400 record still lists
NCT01687400 is an interventional study that assigns participants to a tested intervention. The registered 114 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 (60% lower).
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which decitabine is the first listed.
NCT01687400 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT01687400 about?
NCT01687400 is a clinical study titled "Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes". This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a ...
What is the current status of trial NCT01687400?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2013-02-12. Estimated completion is 2017-11-13.
What conditions does trial NCT01687400 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute.
What interventions are being tested in trial NCT01687400?
The interventions under investigation include: decitabine (DRUG).
Who is sponsoring clinical trial NCT01687400?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01687400 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT01687400's enrollment target sits among peer trials
114 49th of 173 higher than 125 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.
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