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Itacitinib for Graft-versus-Host Disease
Study Summary
This trial is testing if a combination of itacitinib with existing immunosuppressive therapies is safe and effective for treating cGVHD.
- Chronic Graft-versus-Host Disease
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 439 Patients • NCT03139604Trial Design
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- You have received a stem cell transplant from a donor, regardless of how much the donor's genes match yours. It doesn't matter if the transplant used bone marrow, peripheral blood stem cells, or cord blood, or if it was a strong or gentle treatment.You have chronic graft-versus-host disease (cGVHD) that does not respond to steroid treatment.You have had a previous cancer that has come back or required treatment after a stem cell transplant.You have severe problems with your organs that are not caused by the disease being studied.You have liver problems that are not improving or a specific liver disease called veno-occlusive disease that has not been resolved.You have personal, family, social, or geographical circumstances that make it difficult for you to follow the study's rules.
- Group 1: Itacitinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Itacitinib the subject of any other research?
"First researched in 2013, itacitinib has been subjected to 12 trials and is now being studied across 23 active studies. Of these locations, many can be found in the city of Austin, Texas."
Is this experiment a pioneering endeavor in its field?
"Since 2013, Itacitinib has been the subject of numerous clinical trials. The first such study was sponsored by Incyte Corporation and included 121 patients; after a successful conclusion, it subsequently received its Phase 1 drug approval in 2013. Currently, this medication is being tested across 76 cities and 20 countries - with 23 active studies taking place worldwide."
What is the total number of medical facilities currently running this experiment?
"This trial is presently recruiting at 5 different sites, including the cities of Austin, Denver and San Antonio. To reduce time spent travelling to these locations, it would be wise to select a site closest in proximity to you."
Has Itacitinib garnered official governmental approval from the FDA?
"Our team assigned itacitinib a score of 2 since there is early evidence supporting its safety but no clinical data demonstrating effectiveness."
Is the research team currently recruiting participants for this investigation?
"Clinicaltrials.gov reports that this medical trial commenced recruitment on the 5th of June 2020 and was last updated on 24 January 2022, alluding to an open call for patients."
How many participants have thus far enrolled in this research endeavor?
"Incyte Corporation, the sponsor of this investigation, requires forty eligible subjects to commence their study. The sites chosen for recruitment include South Austin Medical Center in Texas and Colorado Blood Cancer Institute located in Denver."
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