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 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
1 other identifier
interventional
182
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2024
Longer than P75 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
December 8, 2025
December 1, 2025
4.9 years
November 6, 2024
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 24
Secondary Outcomes (13)
Best Objective Response Rate (BOR)
Week 24
Duration of Relief (DOR)
Through study completion, an average of 2 year
Improvement in Lee cGVHD symptom score of subjects in week 24
Week 24
Failure free survival (FFS)
Weeks 2, 4, 8, 16, 36, 48, 60, 72, 84, 96
Primary disease recurrence rate (MR)
Weeks 8, 16,24， 36, 48
- +8 more secondary outcomes
Study Arms (2)
Rovadicitinib
EXPERIMENTALRovadicitinib: 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 COMPARATORMethotrexate 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.
Interventions
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 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 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Has experienced or currently suffers from other malignant tumors within the past 3 years;
- Known or suspected active aGVHD；
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, 400038, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China
Lanzhou, Gansu, 730050, China
Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510180, China
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
The Second Hospital of Hebei Medical Hospital
Shijiazhuang, Hebei, 050000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450099, China
Henan Cancer Hospital
Zhenzhou, Henan, 450000, China
Wuhan Union Hospital of China
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, Hunan, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223200, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
First Hospital of Jilin University
Changchun, Jilin, 130031, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Tai'an City Central Hospital
Tai’an, Shandong, 271000, China
Shanghai Jiao Tong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, 200001, China
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, 710068, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, 300052, China
The First Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315211, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325005, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2024
First Posted
November 12, 2024
Study Start
November 20, 2024
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
December 1, 2030
Last Updated
December 8, 2025
Record last verified: 2025-12