Actively Recruiting
Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)
Led by Daihong Liu · Updated on 2026-04-03
54
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the severe acute GVHD (graft-versus-host disease )
CONDITIONS
Official Title
Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hematological diseases.
- Have undergone first allogeneic hematopoietic stem cell transplantation from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.
- New onset of severe acute GVHD within 100 days post-transplantation.
You will not qualify if you...
- Recipients of second allogeneic stem cell transplant.
- Acute GVHD induced by donor lymphocyte infusion or interferon.
- Received first line acute GVHD treatment before enrollment.
- Overlap GVHD syndrome.
- Pregnant or breast-feeding women.
- Absolute neutrophil count less than 0.5 x 10^9/L or platelet count less than 20 x 10^9/L.
- Serum creatinine greater than 2.0 mg/dL or creatinine clearance less than 40 mL/min by Cockroft-Gault equation.
- Uncontrolled infection.
- Human immunodeficiency virus infection.
- Active hepatitis B or C virus infection requiring antiviral treatment.
- Evidence of relapsed primary disease, prior relapse treatment after transplantation, or graft rejection.
- Allergic history to Janus kinase inhibitors.
- Severe organ dysfunction unrelated to GVHD, including unresolved liver veno-occlusive disease or cholestatic disorders.
- Clinically significant or uncontrolled cardiac disease, such as unstable angina, recent myocardial infarction within 6 months, severe heart failure, circulatory collapse requiring support, or arrhythmia needing therapy.
- Clinically significant respiratory disease requiring mechanical ventilation or high oxygen support.
- Received Janus kinase inhibitor therapy after transplantation for any indication.
- Any condition that would interfere with study participation, pose significant risk, or affect data interpretation per investigator judgment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Hematology, the Fifth Center of Chinese PLA General Hospital
Beijing, China, 100853
Actively Recruiting
Research Team
D
Daihong Liu
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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