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Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
Led by Novartis Pharmaceuticals · Updated on 2025-11-26
50
Participants Needed
19
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
CONDITIONS
Official Title
Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent obtained prior to participation
- Male or female Chinese participants aged 12 years or older
- Able to swallow tablets
- Have undergone allogeneic stem cell transplantation from any donor source
- Evidence of myeloid and platelet engraftment with ANC >1,000/mm3 and platelet count ≥25,000/mm3
- Clinically diagnosed moderate to severe chronic graft versus host disease per NIH criteria
- Currently receiving systemic corticosteroids for less than 12 months for cGvHD and confirmed corticosteroid-refractory cGvHD
- Eastern Cooperative Oncology Group performance status of 0-2
You will not qualify if you...
- Received two or more systemic treatments for cGvHD besides corticosteroids �b1 calcineurin inhibitors
- Received ROCK2 inhibitors for cGvHD
- Transitioned from active acute GvHD to chronic GvHD without tapering corticosteroids �b1 calcineurin inhibitors and systemic treatment
- Treated with prior JAK inhibitors for acute GvHD unless off treatment for at least 8 weeks with response
- Failed prior allogeneic stem cell transplant within 6 months before study start
- Relapsed primary malignancy or treated for relapse after transplant
- SR-cGvHD occurring after non-scheduled donor lymphocyte infusion for malignancy relapse
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Novartis Investigative Site
Hefei, Anhui, China, 230001
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2
Novartis Investigative Site
Guangzhou, Guangdong, China, 510000
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3
Novartis Investigative Site
Guangzhou, Guangdong, China, 510515
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4
Novartis Investigative Site
Nanning, Guangxi, China, 530021
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5
Novartis Investigative Site
Guiyang, Guizhou, China, 550004
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6
Novartis Investigative Site
Shijiazhuang, Hebei, China, 050000
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7
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
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8
Novartis Investigative Site
Wuhan, Hubei, China, 430030
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9
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
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10
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
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11
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
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12
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310003
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13
Novartis Investigative Site
Ningbo, Zhejiang, China, 315016
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14
Novartis Investigative Site
Wenzhou, Zhejiang, China, 325000
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15
Novartis Investigative Site
Beijing, China, 100034
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16
Novartis Investigative Site
Beijing, China, 100070
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17
Novartis Investigative Site
Changsha, China, 410000
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18
Novartis Investigative Site
Shanghai, China, 200025
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19
Novartis Investigative Site
Wujiang Nongchang, China, 065201
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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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