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Belumosudil for Graft-versus-Host Disease
Study Summary
This trial is testing a new drug to see if it can help people with a certain type of cancer who have tried other treatments unsuccessfully.
- Chronic Graft-versus-Host Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT02841995Trial Design
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Who is running the clinical trial?
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- You have received between 2 and 5 different types of medication for chronic graft-versus-host disease (cGVHD).Your cancer has come back or you have a specific type of disease after a transplant.You are currently taking ibrutinib, or if you have taken it before, there needs to be a break of at least 28 days before joining the study.You have been taking a stable dose of glucocorticoid therapy for the past 2 weeks before screening.If you are 16 years or older, you should have a Karnofsky Performance Score of 60 or higher.People at least 12 years old who have had a specific type of cell transplant called allogenic hematopoietic cell transplant.You have ongoing symptoms of chronic graft-versus-host disease and need treatment for it.If you're under 16, you need to have a Lansky Performance Score of 60 or higher.You weigh at least 40 kilograms.
- Group 1: Arm B: belumosudil 200 mg BID
- Group 2: Arm A: belumosudil 200 mg QD
- 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
How many medical facilities are actively conducting this trial?
"This trial can be accessed in 24 different medical sites, such as The Cleveland Clinic Foundation, The University of Texas MD Anderson Cancer Center and Children's National Medical Center_Site number 163. Additionally, there are 21 other locations where this study is available."
Is KD025 an acceptable option for people considering potential risks?
"Belumosudil (KD025) has been deemed a 2 on our risk scale due to the existence of some data supporting its safety, though no clinical evidence exists indicating efficacy."
What is the upper limit for enrollment in this research trial?
"Affirmative. Per the clinicaltrials.gov listing, this experiment is actively recruiting participants having been initially posted on October 11th 2018 and last modified on September 18th 2022. The research team needs 175 individuals across 24 sites to take part in the study."
What other experiments involving Belumosudil (KD025) have been recorded in the past?
"Currently, 6 trials are underway for Belumosudil (KD025). None of these active studies have reached Phase 3. Most locations conducting research on this treatment can be found in New york City; however, there are 140 sites running experiments overall."
Is this medical research pioneering an innovative approach?
"Belumosudil (KD025) research has been ongoing since 2018, when it was initially tested by Kadmon Corporation, LLC in a trial of 175 people. Subsequently receiving Phase 2 approval, there are currently 6 live trials for Belumosudil (KD025) across 56 cities and two countries."
Is this trial currently seeking participants?
"Indeed, clinicaltrials.gov data reveals that this experiment is still recruiting participants. It was issued on October 11th 2018 and last amended on September 18th 2022; so far 175 individuals have been accepted at 24 sites."
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