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NCT04281498 · ClinicalTrials.gov registry record · Phase 2
Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation
A Phase 2 study, sponsored by John Mascarenhas.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT04281498: Completed Phase 2 study, sponsored by John Mascarenhas.
NCT04281498 is a Phase 2 study that has completed, run by John Mascarenhas. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04281498, a Phase 2 study, has completed, sponsored by John Mascarenhas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy.
Primary Outcome
The number of treated accelerated-phase and blast-phase MPN patients (primary cohort) that achieve a best response per 2013 International Working Group (IWG) criteria of either complete response (CR), Partial Response (PR), or complete response with incomplete recovery of counts (CRi), when treated with the combination of ruxolitinib with enasidenib within 6 cycles of combined therapy. Complete Response with incomplete recovery of counts (CRi) - complete remission (\<5% marrow blasts by morphol
Interventions
- DRUG Ruxolitinib
- DRUG Enasidenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2023-05-30 |
| Phase | Phase 2 |
What the finished NCT04281498 record still lists
NCT04281498 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Ruxolitinib is the first listed.
NCT04281498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04281498 about?
NCT04281498 is a clinical study titled "Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation". The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effecti...
What is the current status of trial NCT04281498?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2021-01-14. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT04281498?
The interventions under investigation include: Ruxolitinib (DRUG), Enasidenib (DRUG).
Who is sponsoring clinical trial NCT04281498?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04281498's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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