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NCT03683433 · ClinicalTrials.gov registry record · Phase 2
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
A Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03683433: Recruiting Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT03683433 is a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03683433, a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
The study will estimate the ORR for the combination treatment, along with the Bayesian 95% credible interval. ORR will be defined as the proportion of patients who had CR (complete remission), CRh (complete remission with incomplete hematologic recovery), CRi (complete remission with incomplete count recovery), PR (partial response), and/or marrow clearance of blasts (MLFS).
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Enasidenib Mesylate
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2027-09-20 |
| Phase | Phase 2 |
What NCT03683433 shows while recruiting
NCT03683433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (76% lower).
The record links to 7 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine is the first listed.
NCT03683433 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03683433 about?
NCT03683433 is a clinical study titled "Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation". This phase II trial studies how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some o...
What is the current status of trial NCT03683433?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2018-09-18. Estimated completion is 2027-09-20.
What conditions does trial NCT03683433 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Acute Biphenotypic Leukemia.
What interventions are being tested in trial NCT03683433?
The interventions under investigation include: Azacitidine (DRUG), Enasidenib Mesylate (DRUG).
Who is sponsoring clinical trial NCT03683433?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03683433 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndrome
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 NCT03683433's enrollment target sits among peer trials
50 69th of 134 higher than 63 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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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