A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
Stopped early · Phase 2
Conditions studied: Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
In brief
This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol". Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.
Key facts
- Study ID
- NCT04640025
- Run by
- Incyte Corporation
- People needed
- 18
- Starts
- 2021-03-10
- Expected to finish
- 2026-05-11
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
- Currently tolerating treatment as defined by the parent Protocol.
- Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
- Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
- Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
- Willingness to avoid pregnancy or fathering children..
- Ability to comprehend and willingness to sign an ICF.
You may not qualify if…
- Able to access itacitinib therapy commercially.
- Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
- Pregnant or breastfeeding women.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- Anschutz Cancer Pavilion-University of Colorado — Aurora, Colorado, United States
- Parkview Cancer Institute — Fort Wayne, Indiana, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Temple University Department of Thoracic Medicine and Surgery — Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Texas Oncology San Antonio — San Antonio, Texas, United States
- Ordensklinikum Linz Gmbh Elisabethinen — Linz, Austria
- Universitaire Ziekenhuis Leuven - Gasthuisberg — Leuven, Belgium
- Providence Health — Vancouver, British Columbia, Canada
- Universitatsklinikum Halle (Saale) — Halle, Germany
- University Medical Centre Hamburg-Eppendorf Centre of Oncology — Hamburg, Germany
- University Hospital Mannheim — Mannheim, Germany
- University Hospital of West Attica - Attikon — Chaïdári, Greece
- Hadassah Hebrew University Medical Center Ein Karem Hadassah — Jerusalem, Israel
- Azienda Policlinico Vittorio Emanuele — Catania, Italy
- Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti — Reggio Calabria, Italy
- Aou San Giovanni Di Dio E Ruggi — Salerno, Italy
- Hospital Universitario Virgen de Las Nieves — Granada, Spain
- Hospital Universitario Ramon Y Cajal — Madrid, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.