Graft-versus-host DiseasePhase 3NCT06682169
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
A Phase 3 study testing Rovadicitinib, Imatinib and Methotrexate in people with Graft-versus-host Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 41 sites in China.
Trial summary
The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Graft-versus-host Disease
- What is being tested?
- Rovadicitinib, Imatinib and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 41 sitesChina
- Study dates
- 20 Nov 2024to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival period exceeding 6 months;
- Previously received allogeneic hematopoietic stem cell transplantation;
- According to NIH standards, the clinical diagnosis is moderate to severe cGVHD；
- Previously received systematic treatment for cGVHD with 2-5 lines;
- Stable dosage of corticosteroids and other immunosuppressants received within 2 weeks prior to screening;
- The main organ functions well;
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- Starting from Day 1 after enrollment in the control group of this study, participants must receive one of the drugs specified in the study protocol;
- Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study; Serum pregnancy test negative within 7 days prior to enrollment in the study, and must be a non lactating subject; Male participants should agree to use contraceptive measures during the study period and within 6 months after the end of the study period;
- Subjects voluntarily joined this study, signed informed consent, and had good compliance.
Who cannot join
- Has experienced or currently suffers from other malignant tumors within the past 3 years;
- Known or suspected active aGVHD；
- Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolled active infections, or infections requiring systematic treatment within the first 7 days of randomization, except for those deemed suitable for inclusion by the researchers;
- The occurrence and progression of other underlying diseases include post transplant lymphoid tissue proliferative diseases and recurrence of primary malignant hematological diseases;
- Random failure of allogeneic hematopoietic stem cell transplantation within the first 6 months or having received 2 allogeneic hematopoietic stem cell transplants in the past;
- Used JAK inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, etc. within the first 2 weeks of randomization;
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- There are multiple factors that can affect oral medication, such as inability to swallow, intestinal obstruction, etc;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Subjects with any severe and/or uncontrolled illnesses;
- Individuals who are allergic to research drugs or their components;
- Participated in other clinical trials within the first 4 weeks of randomization;
- According to the researcher's judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are deemed unsuitable for inclusion due to other reasons.
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
China41 sites, 41 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yujun Dong, Doctor, 18210264969, dongy@hsc.pku.edu.cn
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaodong Mo, Doctor, 13810096698, mxd453@163.com
- Not yet recruiting
First Hospital of Jilin University
Changchun, Jilin, 130031
Sujun Gao, Doctor, 15843073208, sujung1963@163.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, Hunan
Hongling Peng, Doctor, 18900766137, 577769365@qq.com
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xiaobin Huang, Doctor, 18981838236, 978236463@qq.com
- Not yet recruiting
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, 400038
Shuangnian Xu, Doctor, 13650596553, xushuangnian1985@163.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Nainong Li, Doctor, 13365910189, nainli@aliyun.com
- Not yet recruiting
Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510180
Shunqing Wang, Doctor, 13437801998, shqwang_cn@163.com
- Not yet recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Hua Jin, Doctor, 18026280868, echohua1124@163.com
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
Jishi Wang, Doctor, 13639089646, Wangjishi9646@163.com
Peng Zhao, Doctor, 13639014111, 56068622@qq.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
He Huang, Doctor, 13605714822, hehuangyu@126.com
- Not yet recruiting
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, 230001
Xiaoyu Zhu, Doctor, 15255456091, xiaoyuz@ustc.edu.cn
- Not yet recruiting
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223200
YanMing Zhang, Doctor, 15951268038, zhangyanming2005@126.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jun Peng, Doctor, 18560087005, junpeng88@sina.com
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Yajie Wang, Doctor, 13211630338, 694634285@qq.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Yaming Xi, Doctor, 18693165668, lingxiaolingedu@163.com
- Not yet recruiting
The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China
Lanzhou, Gansu, 730050
Tao Wu, Doctor, 13919939297, wutaozhen@yeah.net
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li, Doctor, 13970038386, lifeigcp2022@163.com
- Not yet recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Zhengping Yu, Doctor, 15951946338, zhengpingyu2016@sina.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Kourong Miao, Doctor, 13813828314, kourongmiao@163.com
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhongming Zhang, Doctor, 15807801369, zzmmissyou@126.com
- Not yet recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040
Ying Lu, Doctor, 13486090834, rmluying@nbu.edu.com
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315211
Ping Zhang, Doctor, 13819811995, lingdujianke@163.com
- Not yet recruiting
Shanghai Jiao Tong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, 200001
Lijing Shen, Doctor, 13917912448, shenlijing@renji.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, 200025
Xiaoxia Hu, Doctor, 13795437259, hu_xiaoxia@126.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Xiaojing Yan, Doctor, 13889128302, yanxiaojing_pp@hotmail.com
- Not yet recruiting
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, Hebei, 050000
Xuejun Zhang, Doctor, 13722781112, zhxjhbmu@126.com
- Not yet recruiting
Tai'an City Central Hospital
Tai’an, Shandong, 271000
Guanchen Bai, Doctor, 18653819776, bgcbgc1@163.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Lifang Huang, Doctor, 13554399000, huanglifang627@163.com
- Not yet recruiting
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, 300052
Erlie Jiang, Doctor, 15122538106, jiangerlie@ihcams.ac.cn
- Not yet recruiting
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Ming Jiang, Doctor, 13909910116, jiangmingyy@126.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325005
Lan Sun, Doctor, 13587685726, sunlan91@126.com
- Not yet recruiting
Wuhan Union Hospital of China
Wuhan, Hubei, 430022
Wei Shi, Doctor, 13207131315, 496020121@qq.com
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030
Fankai Meng, Doctor, 13007115862, 59440029@qq.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Fuling Zhou, Doctor, 18986285580, zhoufuling@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Pengcheng He, Doctor, 18991232609, hpc@163.com
- Not yet recruiting
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068
Yi Wang, Doctor, 13571936193, 13571936193@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Zhifeng Li, Doctor, 13606901162, lzf_xm@163.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zunmin Zhu, Doctor, 13603712008, zhuzm1964@163.com
- Not yet recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450099
Xianjing Wang, Doctor, 13733809362, xianjingwang@126.com
- Recruiting
Henan Cancer Hospital
Zhenzhou, Henan, 450000
Jian Zhou, Doctor, 13623822347, zhoujiandoctor@163.com
About this study
Official title: A Randomized, Open Label, Positive Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of the Selected Regimen of Rovadicitinib in Moderate to Severe Chronic Graft-versus-host Disease in Third Line and Beyond
The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.
- Conditions
- Graft-versus-host Disease
- Being tested
- Rovadicitinib, Imatinib, Methotrexate, Mycophenolate mofetil, Rituximab
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RovadicitinibDrug
Rovadicitinib is an inhibitor of Janus associated kinases (JAK) family and Rho associated kinases (ROCK). It can inhibit the sustained abnormal activation of the Janus kinase (JAK) signal transducer and activator of transcription (JAK-STAT) pathway and also inhibit Rho associated kinase 2 (ROCK2). The JAK 1-JAK 2 signaling pathway is a key step in causing inflammation and tissue damage in acute and chronic graft-versus-host disease.
ImatinibDrug
Imatinib tyrosine kinase inhibitor is a small molecule protein kinase inhibitor that has the ability to block one or more protein kinases. Clinically used for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumors.
MethotrexateDrug
Methotrexate is an organic compound, mainly used as an anti folate anti-tumor drug. It inhibits the synthesis of tumor cells by inhibiting dihydrofolate reductase, thereby inhibiting the growth and reproduction of tumor cells.
Metoprolol ester is an organic compound mainly used as an immunosuppressant
RituximabDrug
Rituximab activates antibody dependent cell-mediated phagocytosis and complement dependent cytotoxicity by binding to cluster of differentiation 20 (CD20) antigen, clearing malignant B cells expressing CD20 and achieving therapeutic goals.
| Study group | Role | What they receive |
|---|---|---|
| Rovadicitinib | Experimental | Rovadicitinib: 10mg, taken orally on an empty stomach twice a day, with a minimum interval of 8 hours between each dose, and an optimal interval of 12 hours. Every 28 days is a treatment cycle. Receives: Drug: Rovadicitinib |
| Imatinib or Methotrexate or Mycophenolate or Rituximab | Active comparator | Methotrexate tablets: 10mg, orally, once a week or 5mg, orally, twice a week.
Metoprolol ester: 250mg-500mg, bid, orally.
Imatinib: 100-400mg, qd, oral.
Rituximab: 375mg/m2, administered intravenously once a week for 4 consecutive weeks. Receives: Drug: Imatinib; Drug: Methotrexate; Drug: Mycophenolate mofetil; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate in the 24th week (ORR)
Researchers evaluated each organ according to the consensus criteria of the NIH 2014 conference, and at week 24, the percentage of subjects with complete response (CR) or partial response (PR) in all assessable organs was determined.
Measured: Week 24
Secondary outcomes (13)
Best Objective Response Rate (BOR)
The best therapeutic effect among all therapeutic outcomes
Measured: Week 24
Duration of Relief (DOR)
The duration of symptom relief for patients after receiving treatment
Measured: Through study completion, an average of 2 year
Improvement in Lee cGVHD symptom score of subjects in week 24
The Lee cGVHD Symptom Score is a tool used to assess the severity of symptoms in chronic graft-versus-host disease (cGVHD), ranging from 0 to 4 points, with a maximum total score of 16 points. The higher the score, the more severe the cGVHD symptoms.
Measured: Week 24
Failure free survival (FFS)
The time from the start of treatment to the occurrence of disease progression or death for any reason in the patient
Measured: Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96
Primary disease recurrence rate (MR)
The probability of recurrence of the patient's disease within a certain period of time.
Measured: Weeks 8, 16,24， 36, 48
Non-Relapse Mortality (NRM)
NRM was defined as death without recurrent or progressive disease
Measured: Weeks 8, 16,24， 36, 48
Overall survival (OS)
From randomization to the time of death caused by any reason
Measured: Through study completion, an average of 2 year
Percentage of subjects whose daily glucocorticoid dose decreased
Percentage of subjects whose daily glucocorticoid dose decreased by ≥ 50% in week 24, and percentage of subjects who discontinued all glucocorticoids
Measured: Week 24
Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
The FACT-BMT scale is a tool used to evaluate the quality of life (QOL) of patients after hematopoietic stem cell transplantation, the scale is filled out by the person closest to the patient, and each question has five possible answers on a scale of 0-4. Answer each question item based on the patient's actual situation in the past week, and mark the corresponding number with a "√"
Measured: Through study completion, an average of 2 year
Changes in 5-level EQ-5D (EQ-5D-5L)
The scoring criteria of EQ-5D-5L scale include five dimensions: action ability, self-care ability, daily activity ability, pain or discomfort, anxiety or depression. After selecting a level for each dimension, a specific rating can be obtained. For example, if an individual chooses "slightly difficult" in terms of action ability, they will score 2 points on that dimension (from 0 to 5, where 0 indicates no difficulty and 5 indicates inability/very serious difficulty)
Measured: Through study completion, an average of 2 year
Adverse events (AE)
The incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators.
Measured: Through study completion, an average of 2 year
Cmax
The maximum concentration of medication that enters the bloodstream after administration
Measured: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
Ctrough
After multiple administrations, the blood drug concentration reaches a relatively stable state, which is called the steady-state concentration
Measured: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start20 Nov 2024
- Primary completionOct 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682169
- Sponsor's protocol ID
- TQ05105-III-01
- Status last verified
- Dec 2025
- First submitted
- 6 Nov 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Positive Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of the Selected Regimen of Rovadicitinib in Moderate to Severe Chronic Graft-versus-host Disease in Third Line and Beyond
- ClinicalTrials.gov ID
- NCT06682169
- Acronym / sponsor ID
- TQ05105-III-01
- Conditions
- Graft-versus-host Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rovadicitinib | Experimental | Drug: RovadicitinibRovadicitinib: 10mg, taken orally on an empty stomach twice a day, with a minimum interval of 8 hours between each dose, and an optimal interval of 12 hours. Every 28 days is a treatment cycle. |
| Imatinib or Methotrexate or Mycophenolate or Rituximab | Active comparator | Drug: Imatinib, Drug: Methotrexate, Drug: Mycophenolate mofetil, Drug: RituximabMethotrexate tablets: 10mg, orally, once a week or 5mg, orally, twice a week. Metoprolol ester: 250mg-500mg, bid, orally. Imatinib: 100-400mg, qd, oral. Rituximab: 375mg/m2, administered intravenously once a week for 4 consecutive weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival period exceeding 6 months;
- Previously received allogeneic hematopoietic stem cell transplantation;
- According to NIH standards, the clinical diagnosis is moderate to severe cGVHD；
- Previously received systematic treatment for cGVHD with 2-5 lines;
- Stable dosage of corticosteroids and other immunosuppressants received within 2 weeks prior to screening;
Key exclusion criteria (12 listed)
- Has experienced or currently suffers from other malignant tumors within the past 3 years;
- Known or suspected active aGVHD；
- Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolled active infections, or infections requiring systematic treatment within the first 7 days of randomization, except for those deemed suitable for inclusion by the researchers;
- The occurrence and progression of other underlying diseases include post transplant lymphoid tissue proliferative diseases and recurrence of primary malignant hematological diseases;
- Random failure of allogeneic hematopoietic stem cell transplantation within the first 6 months or having received 2 allogeneic hematopoietic stem cell transplants in the past;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RovadicitinibRovadicitinib is an inhibitor of Janus associated kinases (JAK) family and Rho associated kinases (ROCK). It can inhibit the sustained abnormal activation of the Janus kinase (JAK) signal transducer and activator of transcription (JAK-STAT) pathway and also inhibit Rho associated kinase 2 (ROCK2). The JAK 1-JAK 2 signaling pathway is a key step in causing inflammation and tissue damage in acute and chronic graft-versus-host disease. | Drug | Rovadicitinib |
| ImatinibImatinib tyrosine kinase inhibitor is a small molecule protein kinase inhibitor that has the ability to block one or more protein kinases. Clinically used for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumors. | Drug | Imatinib or Methotrexate or Mycophenolate or Rituximab |
| MethotrexateMethotrexate is an organic compound, mainly used as an anti folate anti-tumor drug. It inhibits the synthesis of tumor cells by inhibiting dihydrofolate reductase, thereby inhibiting the growth and reproduction of tumor cells. | Drug | Imatinib or Methotrexate or Mycophenolate or Rituximab |
| Mycophenolate mofetilMetoprolol ester is an organic compound mainly used as an immunosuppressant | Drug | Imatinib or Methotrexate or Mycophenolate or Rituximab |
| RituximabRituximab activates antibody dependent cell-mediated phagocytosis and complement dependent cytotoxicity by binding to cluster of differentiation 20 (CD20) antigen, clearing malignant B cells expressing CD20 and achieving therapeutic goals. | Drug | Imatinib or Methotrexate or Mycophenolate or Rituximab |
Primary outcome
Objective remission rate in the 24th week (ORR)
Time frame: Week 24
Researchers evaluated each organ according to the consensus criteria of the NIH 2014 conference, and at week 24, the percentage of subjects with complete response (CR) or partial response (PR) in all assessable organs was determined.
13 secondary outcomes
Best Objective Response Rate (BOR)
Time frame: Week 24
Duration of Relief (DOR)
Time frame: Through study completion, an average of 2 year
Improvement in Lee cGVHD symptom score of subjects in week 24
Time frame: Week 24
Failure free survival (FFS)
Time frame: Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96
Primary disease recurrence rate (MR)
Time frame: Weeks 8, 16,24， 36, 48
Non-Relapse Mortality (NRM)
Time frame: Weeks 8, 16,24， 36, 48
Overall survival (OS)
Time frame: Through study completion, an average of 2 year
Percentage of subjects whose daily glucocorticoid dose decreased
Time frame: Week 24
Changes in the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
Time frame: Through study completion, an average of 2 year
Changes in 5-level EQ-5D (EQ-5D-5L)
Time frame: Through study completion, an average of 2 year
Adverse events (AE)
Time frame: Through study completion, an average of 2 year
Cmax
Time frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
Ctrough
Time frame: Day 1, day 8 on cycle 1: 0.5 hour pre-dose, 0.5 hour after dose, day 1 cycle 2: 0.5 hour pre-dose, 2 hours after dose, day 1 cycle 4: 0.5 hour pre-dose, 3 hours after dose, day 1 cycle 6: 0.5 hour pre-dose, 4 hours after dose (28 days as a cycle)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rovadicitinib, Imatinib and Methotrexate in people with Graft-versus-host Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 41 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang, Doctor (13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate in the 24th week (ORR) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.