Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-V… (NCT03954236) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
United States24 participantsStarted 2019-05-14
Plain-language summary
The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients (≥ 12 years)
* History of allogeneic hematopoietic stem cell transplantation
* BSA of at least 2% of clinically or histologically confirmed non-sclerotic cutaneous chronic graft-versus-host disease (diagnosed and BSA calculated in accordance with the National Institutes of Health Chronic Graft-versus-Host Disease Consensus for Clinical Trials: I. The 2014 Diagnosis and Staging Working Group Report)
* Patients age ≥ 18 years must provide written informed consent; or patients age ≥12 years and \<18 years must provide assent and have at least one guardian provide written informed consent to participate in the study.
* Able to self-administer topical interventions or provide for another person to apply the topical interventions (while wearing nitrile gloves)
* If on systemic therapy for GVHD, systemic therapy must be stable for past 4 weeks; however, any planned systemic corticosteroid taper during the study will be permitted.Changes in systemic therapy during the study period will be allowed for the management of non-skin GVHD.
* Any concurrent topical therapies including topical corticosteroids, topical calcienurin inhibitors, moisturizers, phototherapy (narrowband UVB or UVA1); or excimer laser therapy must be discontinued on Study Day 0.
Exclusion Criteria:
* Known history of allergy to any ingredient of the study medication
* Patients with deep sclerotic cutaneous graft-versus-host disease including deep sclerotic subtypes of chronic cutaneo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing ruxolitinib as a cream applied to the skin — given that I have non-sclerotic cutaneous chronic GvHD, is a topical treatment like this a realistic option for the areas and severity of my skin involvement?
2The trial is in Phase 2, which means researchers are still learning about safety and how well it works — what do we know so far about the risks of using ruxolitinib cream, and how does that uncertainty compare to treatments I could get right now outside a trial?
3Since this study is no longer enrolling new patients, does that mean there's any chance of joining, or should we focus on other options — and is there any way to access ruxolitinib cream through expanded access or another pathway?
4The main thing being measured is how much the affected body surface area shrinks after 28 days — is that timeframe long enough to judge whether a treatment is actually working for my type of GvHD, and what happens to participants after that period ends?
5Are there standard treatments for non-sclerotic cutaneous chronic GvHD that I should consider trying first before looking at a Phase 2 trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in Body Surface Area (BSA) From Day 1 and Day 28