Actively Recruiting
Comparing the Therapeutic Effects of Using Ruxolitinib and Steroids Concurrently to Steroids Alone as Initial Treatment In Patients Diagnosed With Chronic Graft-versus-host Disease at a Grade of Moderate or Higher Severity
Led by Byung-Sik Cho · Updated on 2025-02-19
88
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
B
Byung-Sik Cho
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic graft-versus-host disease (cGVHD) is a complication that occurs in 30-40% of recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) and is a major cause of late non-relapse mortality. In cases where the initial treatment response is inadequate, irreversible tissue damage often persists, making it a fatal complication that significantly reduces quality of life even for long-term survivors. Therefore, the success of first-line treatment is crucial, but to date, there are no approved drugs specifically for the first-line treatment of chronic graft-versus-host disease. Besides corticosteroids, which have been used palliatively for over 50 years, there are no proven effective treatments available. Against this background, this study was designed to explore the potential of new treatments as first-line therapy for chronic graft-versus-host disease, where effective treatment options are currently lacking. Initially, the objective response rate will be analyzed at the 48-week mark based on the NIH Consensus Criteria (Lee 2015). Additionally, the study will evaluate the proportion of patients with steroid-resistant or steroid-dependent conditions, the objective response rate(ORR), failure-free survival(FFS), duration of response(DOR), and the proportion of patients who have reduced corticosteroids. Furthermore, the differences in treatment effects between the two groups of patients will be analyzed based on safety endpoints, including adverse events, laboratory tests, physical examinations, and vital signs.
CONDITIONS
Official Title
Comparing the Therapeutic Effects of Using Ruxolitinib and Steroids Concurrently to Steroids Alone as Initial Treatment In Patients Diagnosed With Chronic Graft-versus-host Disease at a Grade of Moderate or Higher Severity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosed with moderate to severe chronic graft-versus-host disease based on 2014 NIH criteria
- No prior systemic treatment for chronic graft-versus-host disease and currently need systemic corticosteroid treatment
- ECOG performance status of 0 to 2
- Successfully underwent same-type allogeneic stem cell transplantation from marrow, peripheral blood stem cells, or cord blood
- Voluntarily agree to participate in the clinical trial
You will not qualify if you...
- Platelet count less than or equal to 25,000/mm3 without blood transfusion
- Absolute neutrophil count less than or equal to 1,000/mm3
- Total bilirubin over 3 times the upper limit of normal for reasons other than chronic graft-versus-host disease
- Gastrointestinal issues impairing oral intake or absorption of medications
- History of graft-versus-host disease treatment except limited corticosteroid use within 72 hours before randomization
- Cannot start prednisone treatment at 0.5 mg/kg/day or higher
- Engraftment failure of stem cell transplant within 6 months before screening
- Prior ruxolitinib use for acute graft-versus-host disease within 4 weeks before randomization
- Chronic graft-versus-host disease after unscheduled donor lymphocyte infusion for cancer recurrence prevention
- History of relapsed primary malignancy, unregulated sinusoidal obstruction syndrome, progressive multifocal leukoencephalopathy, severe nephropathy, active uncontrolled infections, active tuberculosis, HIV infection, significant hepatitis B or C infection, or serious cardiovascular disease
- Allergic or sensitive to study drug components or similar compounds
- Genetic disorders affecting carbohydrate absorption
- Taking more than 200 mg of Fluconazole daily
- Use of systemic blood coagulation or platelet function inhibitors except aspirin up to 150 mg/day
- Pregnant or breastfeeding women
- Not agreeing to use effective contraception during the study and for 30 days after
- Participation in another clinical trial with investigational product use within 30 days before screening
- Investigator considers participation inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Banpo-daero/Seocho-gu, South Korea, 06591
Actively Recruiting
Research Team
B
ByungSik Cho, M.D. & Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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