Comparing Rovadicitinib to Other Treatments for Chronic Graft-versus-host Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Rovadicitinib in patients with moderate to severe chronic graft-versus-host disease (cGVHD) who have already undergone multiple lines of treatment. Participants will be compared to a control group receiving a treatment protocol selected by researchers. The primary outcome is to assess the objective response rate at week 24. Eligible patients must have received allogeneic hematopoietic stem cell transplantation and have stable organ function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Cancer Hospital
  Zhenzhou, Henan, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of USTC Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The Southwest Hospital of AMU
  Chongqing, Chongqing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: He Huang, Doctor
• Email: hehuangyu@126.com
• Phone: 13605714822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ruxolitinib for Graft-Versus-Host Disease in Clinical Practice

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• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

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  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• Cord blood transplant for children and young adults with blood cancers.

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  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT07566377

• Ruxolitinib maintenance after stem cell transplant for T‑cell lymphoma

  This phase II trial tests whether taking ruxolitinib after a stem cell transplant can lower the chance of relapse and graft‑versus‑host disease for people treated for T‑cell lymphoma.

  Recruiting at 2 sites Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio and 1 other locations · NCT07356245

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.