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Evaluation of Rovadicitinib C...

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

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Graft-versus-host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rovadicitinib

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.

Group Type EXPERIMENTAL

Rovadicitinib

Intervention Type DRUG

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 or Methotrexate or Mycophenolate or Rituximab

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.

Group Type ACTIVE_COMPARATOR

Imatinib

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Metoprolol ester is an organic compound mainly used as an immunosuppressant

Rituximab

Intervention Type DRUG

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.

Interventions

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Rovadicitinib

Intervention Type DRUG

Imatinib

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Mycophenolate mofetil

Metoprolol ester is an organic compound mainly used as an immunosuppressant

Intervention Type DRUG

Rituximab

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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