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NCT05282459 · ClinicalTrials.gov registry record · Phase 1
Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation
A Phase 1 study of Leukemia and Leukemia, Myeloid, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT05282459: Completed Phase 1 study of Leukemia and Leukemia, Myeloid, sponsored by Stanford University.
NCT05282459 is a Phase 1 study of Leukemia and Leukemia, Myeloid that has completed, run by Stanford University. The registered enrollment target is 17 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05282459, a Phase 1 study of Leukemia and Leukemia, Myeloid, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1b/2, open-label, single arm study to evaluate if enasidenib is safe and effective in improving anemia and decreasing transfusion needs in subjects diagnosed with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) without a mutation in isocitrate dehydrogenase type 2 (IDH2 wildtype). Other objectives include assessment of improvements in platelet production and characterization of the mechanism of action of enasidenib in enhancing endogenous erythropoiesis.
Primary Outcome
Clinical response was assessed as the number of participants achieving a hematological improvement - erythroid (HI-E). Participants were characterized and stratified as nontransfused (NTD), low-transfusion burden (LTB) and high-transfusion burden (HTB), with response defined as follows. * NTD = greater than or equal to 2 consecutive Hb measurements, greater than or equal to 1.5 g/dL for a period of minimum 8 week in an observation period of 16 to 24 week compared to the lowest mean of 2 Hb meas
Conditions Studied
Interventions
- DRUG Enasidenib mesylat dose escalation
Study Locations (1)
California
- Stanford Cancer Institute - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-01-12 |
| Est. Completion | 2025-03-03 |
| Phase | Phase 1 |
What the finished NCT05282459 record still lists
NCT05282459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Enasidenib mesylat dose escalation is the first listed.
NCT05282459 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05282459 about?
NCT05282459 is a clinical study titled "Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation". This is a phase 1b/2, open-label, single arm study to evaluate if enasidenib is safe and effective in improving anemia and decreasing transfusion needs in subjects diagnosed with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) without a mutation i...
What is the current status of trial NCT05282459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-01-12. Estimated completion is 2025-03-03.
What conditions does trial NCT05282459 study?
This clinical trial studies the following conditions: Leukemia, Leukemia, Myeloid, Monocytic Leukemia.
What interventions are being tested in trial NCT05282459?
The interventions under investigation include: Enasidenib mesylat dose escalation (DRUG).
Who is sponsoring clinical trial NCT05282459?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05282459 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05282459's enrollment target sits among peer trials
17 193rd of 233 higher than 40 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
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