OncoMatch/Clinical Trials/NCT06756061
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
Is NCT06756061 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Prednisone + Jakavi(ruxolitinib) and Prednisone for gvhd - graft-versus-host disease.
Treatment: Prednisone + Jakavi(ruxolitinib) · Prednisone — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage MODERATE, SEVERE (2014 NIH consensus criteria)
moderate to severe chronic graft-versus-host disease according to 2014 NIH consensus criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: allogeneic stem cell transplant
successfully taken same-type stem cell transplantation (alloSCT) from the marrow, peripheral blood stem cell, or cord blood
Cannot have received: systemic treatment for chronic graft-versus-host disease
Exception: Corticosteroid administration is permitted for chronic graft-versus-host disease treatment within 72 hours before the randomization visit
no history of systemic treatment for chronic graft-versus-host disease and now need systemic corticosteroid treatment
Cannot have received: ruxolitinib (ruxolitinib)
Exception: No ruxolitinib administration within 4 weeks before the randomization visit; permitted if prior use for acute GVHD with complete/partial response or for another disease and >4 weeks since last dose
experience of ruxolitinib administration for acute graft-versus-host disease treatment (however, the patient may participate on the assumption that the response to the acute graft-versus-host disease treatment reaches the level of complete or partial response and that there is no ruxolitinib administration history within 4 weeks before the randomization visit. In addition, if ruxolitinib administration was for another disease, the patient may participate unless there is no history of ruxolitinib administration within 4 weeks before the randomization visit.)
Lab requirements
Blood counts
platelet count > 25,000/mm3 without blood transfusion; absolute neutrophil count > 1,000/mm3
Kidney function
creatinine clearance rate ≥ 30 mL/min (Cockroft Gault equation)
Liver function
total bilirubin ≤ 3 x ULN unless due to chronic graft-versus-host disease
platelet count is less than or equal to 25,000/mm3 without blood transfusion; absolute neutrophil count is less than or equal to 1,000/mm3; total bilirubin > 3 x ULN for any reason other than chronic graft-versus-host disease; nephropathy whose creatinine clearance rate is lower than 30 mL/min (Cockroft Gault equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify