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

CTTQ

Status and phase: Enrolling; Phase 3

Conditions: Graft-versus-host Disease

Treatments: Drug: Mycophenolate mofetil; Drug: Rovadicitinib; Drug: Imatinib; Drug: Methotrexate; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06682169

TQ05105-III-01

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Rovadicitinib

Experimental group

Description:

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.

Treatment:

Drug: Rovadicitinib

Imatinib or Methotrexate or Mycophenolate or Rituximab

Active Comparator group

Description:

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.

Treatment:

Drug: Rituximab

Drug: Methotrexate

Drug: Imatinib

Drug: Mycophenolate mofetil