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Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease
Led by Novartis Pharmaceuticals · Updated on 2025-11-25
36
Participants Needed
17
Research Sites
189 weeks
Total Duration
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AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).
CONDITIONS
Official Title
Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female Chinese participants aged 12 years or older at the time of informed consent
- Able to swallow tablets
- Have undergone allogeneic stem cell transplantation from any donor source
- Clinically diagnosed with Grade II to IV acute graft versus host disease requiring systemic immune suppressive therapy
- Confirmed myeloid and platelet engraftment within 48 hours before starting ruxolitinib
- Confirmed steroid-refractory acute graft versus host disease based on specified criteria related to corticosteroid treatment response
You will not qualify if you...
- Received more than one systemic treatment for steroid-refractory acute graft versus host disease
- Received JAK inhibitor therapy after current transplantation conditioning
- Clinical presentation resembling de novo chronic graft versus host disease or overlap syndrome
- Failed prior allogeneic stem cell transplantation within the past 6 months
- Presence of relapsed primary malignancy after transplantation
- Active uncontrolled infection requiring treatment
- Steroid-refractory acute graft versus host disease occurring after non-scheduled donor lymphocyte infusion for malignancy recurrence
- Significant respiratory disease, severely impaired kidney function, uncontrolled heart disease, unresolved cholestatic or liver disorders not related to graft versus host disease
- Disorders or therapies interfering with blood clotting or platelet function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
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2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510515
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3
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
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4
Novartis Investigative Site
Wuhan, Hubei, China, 430030
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5
Novartis Investigative Site
Changchun, Jilin, China, 130021
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6
Novartis Investigative Site
Xian, Shanxi, China, 710061
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7
Novartis Investigative Site
Chengdu, Sichuan, China, 610072
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8
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310003
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9
Novartis Investigative Site
Beijing, China, 100028
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10
Novartis Investigative Site
Beijing, China, 100034
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11
Novartis Investigative Site
Beijing, China, 100039
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12
Novartis Investigative Site
Beijing, China, 100070
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13
Novartis Investigative Site
Dalian, China, 116000
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14
Novartis Investigative Site
Fuzhou, China, 350001
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15
Novartis Investigative Site
Shanghai, China, 200025
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16
Novartis Investigative Site
Taian, China, 271099
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17
Novartis Investigative Site
Tianjin, China, 300020
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Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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