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NCT04071366 · ClinicalTrials.gov registry record · Phase 2
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
A Phase 2 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT04071366: Completed Phase 2 study, sponsored by Incyte Corporation.
NCT04071366 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04071366, a Phase 2 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive an approved immune effector cell (IEC) therapy for hematologic malignancies.
Primary Outcome
The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \>6 liters/minute), facemask, nonr
Interventions
- DRUG Placebo
- DRUG Itacitinib
- DRUG Immune effector cell therapy
- BIOLOGICAL Yescarta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2023-08-22 |
| Phase | Phase 2 |
What the finished NCT04071366 record still lists
NCT04071366 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04071366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04071366 about?
NCT04071366 is a clinical study titled "A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy". "The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive an approved immune effector cell (IEC) therapy for hematolo...
What is the current status of trial NCT04071366?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2020-02-07. Estimated completion is 2023-08-22.
What interventions are being tested in trial NCT04071366?
The interventions under investigation include: Placebo (DRUG), Itacitinib (DRUG), Immune effector cell therapy (DRUG), Yescarta (BIOLOGICAL).
Who is sponsoring clinical trial NCT04071366?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04071366's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 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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