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New hope for transplant patients with severe chronic GVHD

NCT ID NCT06682169

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, rovadicitinib, for people with moderate to severe chronic graft-versus-host disease (cGVHD) after a stem cell transplant. Participants must have tried at least two prior treatments. The goal is to see if rovadicitinib improves symptoms better than standard care at 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft versus host disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chinese Academy of Medical Sciences Hematology Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300052, China

  • First Hospital of Jilin University

    NOT_YET_RECRUITING

    Changchun, Jilin, 130031, China

  • Fujian Medical University Union Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guangzhou First People's Hospital The First People's Hospital Affiliated to Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Henan Cancer Hospital

    RECRUITING

    Zhenzhou, Henan, 450000, China

  • Henan Provincial People's Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450003, China

  • Huai'an Second People's Hospital

    NOT_YET_RECRUITING

    Huai'an, Jiangsu, 223200, China

  • Jiangsu Province Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Nanfang Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Peking University First Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100034, China

  • Peking University People's Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250012, China

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Jiao Tong University School of Medicine，Renji Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200001, China

  • Shanxi Bethune Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030032, China

  • Shanxi Provincial People's Hospital

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710068, China

  • Sichuan Provincial People's Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, 610072, China

  • Tai'an City Central Hospital

    NOT_YET_RECRUITING

    Tai’an, Shandong, 271000, China

  • The 904 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730050, China

  • The Affiliated Hospital of Guizhou Medical University

    NOT_YET_RECRUITING

    Guiyang, Guizhou, 550001, China

  • The Affiliated People's Hospital of Ningbo University

    NOT_YET_RECRUITING

    Ningbo, Zhejiang, 315040, China

  • The First Affiliated Hospital of Guangxi Medical University

    NOT_YET_RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Ningbo University

    NOT_YET_RECRUITING

    Ningbo, Zhejiang, 315211, China

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, 325005, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Affiliated Hospital of Xiamen University

    NOT_YET_RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, 110001, China

  • The First Hospital of Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730000, China

  • The First Hospital of Xinjiang Medical University

    NOT_YET_RECRUITING

    Ürümqi, Xinjiang, 830054, China

  • The First People's Hospital of Yunnan Province

    NOT_YET_RECRUITING

    Kunming, Yunnan, 650032, China

  • The Second Hospital of Hebei Medical Hospital

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • The Second Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, Hunan, China

  • The Southwest Hospital of AMU

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, 400038, China

  • The Third People's Hospital of Zhengzhou

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450099, China

  • Tongji Hospital Tongji Medical College of HUST

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430030, China

  • Wuhan Union Hospital of China

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430022, China

  • Zhongda Hospital Southeast University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Zhongnan Hospital of Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, 430071, China

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Other studies related to the condition(s) this trial covers.