A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
This study is looking into a new oral medicine called Belumosudil for people aged 12 and above who have recently been diagnosed with moderate to severe chronic Graft-versus-Host Disease (cGVHD). cGVHD is a common complication after a stem cell or bone marrow transplant. Participants will receive either Belumosudil with steroids or a dummy pill (placebo) with steroids. The main goal is to find out if Belumosudil, when added to steroids, can help manage cGVHD more effectively. This is a Phase 3 study, meaning it's one of the final stages of testing before a medicine could potentially become widely available. The study will carefully monitor participants’ health and the effects of the treatment over time.
At a glance
What is this study about?
You're reading about a research study for people who have chronic Graft-versus-Host Disease (cGVHD). This condition can sometimes happen after a stem cell or bone marrow transplant, where new immune cells from the donor unfortunately start to attack the recipient's healthy tissues. It can cause a range of symptoms, from mild to quite severe.
This particular study is focusing on individuals who have recently been diagnosed with moderate or severe cGVHD. We are exploring a new oral medicine called Belumosudil. The aim is to see if adding Belumosudil to the usual steroid treatment can improve how well cGVHD is managed compared to just using steroids and a dummy pill (placebo). Steroids like Prednisone or Prednisolone are common treatments for cGVHD, but researchers are always looking for ways to make treatments more effective and improve people's quality of life.
By taking part, you would be helping doctors and scientists learn more about cGVHD and how best to treat it. This information is crucial for developing better treatment options for others in the future. The study is very carefully designed and will closely monitor your health and any effects of the treatment.
Key takeaways
- This study is for newly diagnosed moderate to severe cGVHD.
- It tests a new medicine, Belumosudil, with standard steroid treatment.
- Participants must be aged 12 or older.
- You might receive the new medicine or a dummy pill (placebo).
- Participation involves regular check-ups and can last up to 2.5 years.
Who may be eligible?
To join this study, you need to be at least 12 years old and have been recently diagnosed with moderate to severe chronic Graft-versus-Host Disease (cGVHD) after a transplant. You must also need steroid medication for your cGVHD and should not have received any other specific treatments for cGVHD before.
There are also some physical requirements depending on your age, for example, adults need to weigh at least 40 kg, and adolescents at least 30 kg. Both men and women will need to use suitable contraception if there's a chance of pregnancy. Before signing up, you or your legal representative must fully understand and agree to participate.
You would not be able to join if your original disease (the one that led to the transplant) has come back. Also, if you're pregnant or breastfeeding, or if you've already tried Belumosudil or other similar investigational medicines recently, you wouldn't be eligible. The team will review your full medical history to make sure the study is a good fit for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 12 years old or older?
- Have you recently been diagnosed with moderate or severe cGVHD?
- Do you need steroid treatment for your cGVHD?
- Have you NOT received other specific cGVHD treatments before?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you decide to join, your journey in the study would start with a screening period of up to 4 weeks, where doctors will check if the study is right for you. After that, if you're eligible, you'll start your treatment.
You'll be taking the study medication (either Belumosudil or a placebo, alongside steroids) for a period that could vary. This treatment will continue unless your cGVHD gets worse and needs a different treatment, your original disease comes back, or you experience side effects that make it unsafe to continue. You can also choose to stop participating at any time, or the study team might decide it's best for you to stop.
After you stop taking the study medication, you'll have at least 30 days of follow-up appointments. During this time, the team will check on any side effects to make sure they've gone away or are stable. After this, there will be a long-term follow-up period, which could last up to 2.5 years, or until the end of the study. This is to understand the long-term effects of the treatment. Throughout the study, you'll have regular visits and assessments to monitor your health and the progress of your cGVHD.
Potential risks and benefits
Locations (151)
- University of Arkansas for Medical Sciences-Site Number : 8400019Verified postcodeLittle Rock, United States
- City of Hope National Medical Center- Site Number : 8400001Verified postcodeDuarte, United States
- University of California San Francisco - Parnassus Heights- Site Number : 8400035Verified postcodeSan Francisco, United States
- AdventHealth Orlando- Site Number : 8400023Verified postcodeOrlando, United States
- The Hope Clinic of Emory University- Site Number : 8400020Verified postcodeDecatur, United States
- Northwestern University- Site Number : 8400017Verified postcodeChicago, United States
- Indiana University Health University Hospital- Site Number : 8400006Verified postcodeIndianapolis, United States
- University of Kentucky Chandler Medical Center- Site Number : 8400024Verified postcodeLexington, United States
- Johns Hopkins Hospital- Site Number : 8400033Verified postcodeBaltimore, United States
- Dana Farber Cancer Institute Site Number : 8400005Verified postcodeBoston, United States
- Karmanos Cancer Institute - Detroit- Site Number : 8400013Verified postcodeDetroit, United States
- UNC Children's Hospital- Site Number : 8400025Verified postcodeChapel Hill, United States
Common questions
What is chronic Graft-versus-Host Disease (cGVHD)?
It's a complication that can happen after a stem cell or bone marrow transplant, where the donor's immune cells start to attack the patient's own body.
What is Belumosudil?
It's a new oral (taken by mouth) medicine that researchers are testing to see if it helps manage cGVHD when combined with steroids.
Will I definitely get the new medicine?
No, participants will either receive Belumosudil with steroids or a dummy pill (placebo) with steroids. This helps researchers fairly compare the treatments.
How long will I be in the study?
The treatment period varies, but there will be at least 30 days of follow-up for side effects, and long-term follow-up could last up to 2.5 years.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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