Actively Recruiting
A Randomized, Open Label, Positive Controlled, Multicenter Phase III Trial Evaluating Rovadicitinib Versus Selected Treatments in Moderate to Severe Chronic Graft-versus-host Disease in Third Line and Beyond
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-08
182
Participants Needed
41
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of rovadicitinib compared to other treatments chosen by doctors in people with moderate to severe chronic graft-versus-host disease (cGVHD) who have already tried two or more treatments. The study aims to see if rovadicitinib can improve the rate of disease response after 24 weeks. This is a phase III clinical trial conducted by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and involves participants aged 18 to 70 years who have undergone allogeneic hematopoietic stem cell transplantation and have moderate to severe cGVHD. Participants will receive either rovadicitinib, taken orally at 10 mg twice daily on an empty stomach with 28-day treatment cycles, or one of several comparator drugs including methotrexate, metoprolol ester, imatinib, or rituximab according to the study protocol. The comparator treatments include weekly or twice-weekly oral methotrexate, daily oral metoprolol ester, daily oral imatinib, or weekly intravenous rituximab for 4 weeks. The study is randomized and open label, meaning both participants and researchers know which treatment is given. During the study, participants will be monitored for their response to treatment at 24 weeks, including symptom improvement and survival rates over an average of 2 years. Researchers will assess multiple outcomes such as the duration of relief, failure-free survival, disease recurrence, mortality, changes in quality of life, and adverse events. Blood samples will be taken at specified times to measure drug levels. Participants will be followed regularly to track their health and treatment effects throughout the study duration.
CONDITIONS
Brief Title
Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old
- Karnofsky performance score of 60 points or higher
- Expected survival longer than 6 months
- Previously received allogeneic hematopoietic stem cell transplantation
- Clinical diagnosis of moderate to severe chronic graft-versus-host disease by NIH standards
- Previously treated with 2 to 5 lines of systemic therapy for cGVHD
- Stable dose of corticosteroids and other immunosuppressants for at least 2 weeks prior to screening
- Main organs functioning well
- Willing to receive one of the study drugs per protocol if assigned to control group
- Female participants of childbearing potential must use contraception during the study and for 6 months after, have a negative pregnancy test within 7 days prior to enrollment, and not be breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after
- Voluntarily agree to participate and provide informed consent with good compliance
You will not qualify if you...
- History or current diagnosis of other malignant tumors within the past 3 years
- Known or suspected active acute graft-versus-host disease
- Interstitial pneumonia, non-infectious pneumonia, uncontrolled active infections, or infections requiring systemic treatment within 7 days before randomization unless approved by researchers
- Other underlying diseases including post-transplant lymphoproliferative disorders or recurrence of primary malignant hematological diseases
- Failure of allogeneic hematopoietic stem cell transplantation within 6 months or having received 2 prior allogeneic transplants
- Use of JAK inhibitors, BTK inhibitors, or similar drugs within 2 weeks before randomization
- Conditions affecting oral medication intake such as inability to swallow or intestinal obstruction
- History of psychotropic drug abuse or psychiatric disorders that cannot be controlled
- Severe and/or uncontrolled illnesses
- Allergy to study drugs or their components
- Participation in other clinical trials within 4 weeks before randomization
- Any condition that endangers safety or affects study completion as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles during the study period
Participants receive assigned study drugs including Rovadicitinib or comparator treatments such as Imatinib, Methotrexate, Mycophenolate mofetil, or Rituximab to manage moderate to severe chronic graft-versus-host disease.
Regular visits for treatment cycles and assessments approximately every 4 weeks
Duration - Up to 2 years after treatment
Participants are monitored for treatment response, adverse events, and survival outcomes after completing treatment.
Scheduled visits at Weeks 2, 4, 8, 16, 24, 36, 48, 60, 72, 84, and 96 for safety and efficacy assessments
Trial Site Locations
Total: 41 locations
1
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
4
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
5
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
6
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
7
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
9
Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China, 510180
Not Yet Recruiting
10
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
11
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
12
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550001
Not Yet Recruiting
13
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
14
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
15
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450099
Not Yet Recruiting
16
Henan Cancer Hospital
Zhenzhou, Henan, China, 450000
Actively Recruiting
17
Wuhan Union Hospital of China
Wuhan, Hubei, China, 430022
Not Yet Recruiting
18
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
Not Yet Recruiting
19
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Not Yet Recruiting
20
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, Hunan
Not Yet Recruiting
21
Huai'an Second People's Hospital
Huai'an, Jiangsu, China, 223200
Not Yet Recruiting
22
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
23
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
24
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
25
First Hospital of Jilin University
Changchun, Jilin, China, 130031
Not Yet Recruiting
26
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Not Yet Recruiting
27
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
28
Tai'an City Central Hospital
Tai’an, Shandong, China, 271000
Not Yet Recruiting
29
Shanghai Jiao Tong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, China, 200001
Not Yet Recruiting
30
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
31
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Not Yet Recruiting
32
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
33
Shanxi Provincial People's Hospital
Xi’an, Shanxi, China, 710068
Not Yet Recruiting
34
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
35
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, China, 300052
Not Yet Recruiting
36
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
Not Yet Recruiting
37
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China, 650032
Not Yet Recruiting
38
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
39
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China, 315040
Not Yet Recruiting
40
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315211
Not Yet Recruiting
41
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325005
Not Yet Recruiting
Research Team
H
He Huang, Doctor
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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