Status:
RECRUITING
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
The Third Xiangya Hospital of Central South University
Anhui Provincial Cancer Hospital
Conditions:
Mantle Cell Lymphoma (MCL)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituxim...
Eligibility Criteria
Inclusion
- Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
- Age \> 18 years of age, both genders are eligible.
- Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
- At least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 \> 50%, TP53 abnormality, blastic or pleomorphic variation.
- Patients who are not suitable candidates for autologous hematopoietic stem cell transplantation.
- Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\^9/L, absolute neutrophil count ≥1.5×10\^9/L, hemoglobin ≥90g/L, platelet count ≥75×10\^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L.
- The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.
- Willing and able to participate in all required assessments and procedures of the study protocol.
Exclusion
- Patients who have previously received treatment with BTK inhibitors.
- Patients with severe complications or serious infections.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
- Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
- HIV-infected individuals.
- Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
- Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06496308
Start Date
July 10 2024
End Date
July 10 2027
Last Update
July 11 2024
Active Locations (1)
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1
Ruijin Hospital
Shanghai, China, 200025