A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
- Conditions
- MyelofibrosisPostlung Transplant (Bronchiolitis Obliterans)Chronic Graft Versus Host Disease
- Interventions
- Registration Number
- NCT04640025
- Lead Sponsor
- Incyte Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description itacitinib itacitinib Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Events (TEAE's) 3 years Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
University Hospital Mannheim
๐ฉ๐ชMannheim, Germany
Azienda Policlinico Vittorio Emanuele
๐ฎ๐นCatania, Italy
Aou San Giovanni Di Dio E Ruggi
๐ฎ๐นSalerno, Italy
Texas Oncology San Antonio
๐บ๐ธSan Antonio, Texas, United States
Hospital Universitario Ramon Y Cajal
๐ช๐ธMadrid, Spain
University Medical Centre Hamburg-Eppendorf Centre of Oncology
๐ฉ๐ชHamburg, Germany
Ordensklinikum Linz Gmbh Elisabethinen
๐ฆ๐นLinz, Austria
Anschutz Cancer Pavilion-University of Colorado
๐บ๐ธAurora, Colorado, United States
Hospital Universitario Virgen de Las Nieves
๐ช๐ธGranada, Spain
Universitatsklinikum Halle (Saale)
๐ฉ๐ชHalle, Germany
Cleveland Clinic
๐บ๐ธCleveland, Ohio, United States
Parkview Cancer Institute
๐บ๐ธFort Wayne, Indiana, United States
Temple University Department of Thoracic Medicine and Surgery
๐บ๐ธPhiladelphia, Pennsylvania, United States
Sarah Cannon Research Institute
๐บ๐ธNashville, Tennessee, United States
University Hospital of West Attica - Attikon
๐ฌ๐ทChaidari, Greece
Universitaire Ziekenhuis Leuven - Gasthuisberg
๐ง๐ชLeuven, Belgium
City of Hope National Medical Center
๐บ๐ธDuarte, California, United States
Providence Health
๐จ๐ฆVancouver, British Columbia, Canada
Hadassah Hebrew University Medical Center Ein Karem Hadassah
๐ฎ๐ฑJerusalem, Israel
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
๐ฎ๐นReggio Di Calabria, Italy
Hospital of the University of Pennsylvania
๐บ๐ธPhiladelphia, Pennsylvania, United States