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NCT03383575 · ClinicalTrials.gov registry record · Phase 2
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
A Phase 2 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 3
- Study locations
NCT03383575: Recruiting Phase 2 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT03383575 is a Phase 2 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 63 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (46% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03383575, a Phase 2 study of Acute Myeloid Leukemia and Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Will use the Bayesian method by Thall, Simon and Estey for toxicity monitoring. For purpose of toxicity monitoring, toxicity is defined as any grade 3 or higher treatment related-toxicities by Common Terminology Criteria for Adverse Events criteria.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Azacitidine
- DRUG Enasidenib
Study Locations (3)
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Ohio
- Cleveland Clinic Foundation - Cleveland
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2018-01-17 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 2 |
What NCT03383575 shows while recruiting
NCT03383575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (46% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03383575 reports a single indexed study location in Maryland, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT03383575 about?
NCT03383575 is a clinical study titled "Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome". This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT03383575?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2018-01-17. Estimated completion is 2027-02-28.
What conditions does trial NCT03383575 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome With Excess Blasts, Recurrent High Risk Myelodysplastic Syndrome, IDH2 Gene Mutation.
What interventions are being tested in trial NCT03383575?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Azacitidine (DRUG), Enasidenib (DRUG).
Who is sponsoring clinical trial NCT03383575?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03383575 being conducted?
This trial has 3 study locations across Maryland, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
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 NCT03383575's enrollment target sits among peer trials
63 116th of 306 higher than 190 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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