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Clinical Trials in China / NCT06682169
Recruiting Phase 3

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

NCT06682169 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 3
Started
2024-11-20
Last updated
2025-12-08

Condition(s) studied

Graft-versus-host Disease

Investigational drug(s) / intervention(s)

RovadicitinibImatinibMethotrexateMycophenolate mofetilRituximab

Rovadicitinib: 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.

Imatinib: 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.

Methotrexate: 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.

Mycophenolate mofetil: Metoprolol ester is an organic compound mainly used as an immunosuppressant

Rituximab: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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; * 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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
The First Affiliated Hospital of USTC Anhui Provincial Hospital Hefei Anhui Not Yet Recruiting
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
Peking University People's Hospital Beijing Beijing Municipality Not Yet Recruiting
The Southwest Hospital of AMU Chongqing Chongqing Municipality Not Yet Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Not Yet Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Not Yet Recruiting
The First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China Lanzhou Gansu Not Yet Recruiting
Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
Nanfang Hospital Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Not Yet Recruiting
The Second Hospital of Hebei Medical Hospital Shijiazhuang Hebei Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
The Third People's Hospital of Zhengzhou Zhengzhou Henan Not Yet Recruiting
Henan Cancer Hospital Zhenzhou Henan Recruiting
Wuhan Union Hospital of China Wuhan Hubei Not Yet Recruiting
Tongji Hospital Tongji Medical College of HUST Wuhan Hubei Not Yet Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Huai'an Second People's Hospital Huai'an Jiangsu Not Yet Recruiting
Zhongda Hospital Southeast University Nanjing Jiangsu Not Yet Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
First Hospital of Jilin University Changchun Jilin Not Yet Recruiting
The First Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Not Yet Recruiting
Tai'an City Central Hospital Tai’an Shandong Not Yet Recruiting
Shanghai Jiao Tong University School of Medicine,Renji Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Xi’an Shanxi Not Yet Recruiting
Shanxi Provincial People's Hospital Xi’an Shanxi Not Yet Recruiting
Sichuan Provincial People's Hospital Chengdu Sichuan Not Yet Recruiting
Chinese Academy of Medical Sciences Hematology Hospital Tianjin Tianjin Municipality Not Yet Recruiting
The First Hospital of Xinjiang Medical University Ürümqi Xinjiang Not Yet Recruiting
The First People's Hospital of Yunnan Province Kunming Yunnan Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
The Affiliated People's Hospital of Ningbo University Ningbo Zhejiang Not Yet Recruiting
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang Not Yet Recruiting

+ 1 more sites — see the full list on the official registry below.

On this site

📄 Gleevec (imatinib) drug profile → 📄 Rituxan (rituximab) drug profile →

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06682169 on ClinicalTrials.gov ↗ ← All trials in China