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NCT03846479 · ClinicalTrials.gov registry record · Phase 2
Itacitinib for Low Risk GVHD
A Phase 2 study, sponsored by John Levine.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT03846479: Completed Phase 2 study, sponsored by John Levine.
NCT03846479 is a Phase 2 study that has completed, run by John Levine. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03846479, a Phase 2 study, has completed, sponsored by John Levine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.
Primary Outcome
Number of patients who achieve CR or PR by day 28 of treatment with itacitinib without the addition of any other systemic GVHD treatment including steroids. Complete Response (CR): All evaluable organs (skin, liver, GI tract) stage 0. For a response to be scored as CR on day 28, the patient must be in CR on that day and have had no intervening additional GVHD therapy. Partial Response (PR): An improvement in one or more organ involved with GVHD symptoms without worsening in others. For a respo
Interventions
- DRUG Itacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 2 |
What the finished NCT03846479 record still lists
NCT03846479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Itacitinib is the first listed.
NCT03846479 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03846479 about?
NCT03846479 is a clinical study titled "Itacitinib for Low Risk GVHD". Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be ...
What is the current status of trial NCT03846479?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2019-03-25. Estimated completion is 2022-05-11.
What interventions are being tested in trial NCT03846479?
The interventions under investigation include: Itacitinib (DRUG).
Who is sponsoring clinical trial NCT03846479?
This trial is sponsored by John Levine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03846479's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 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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