Status:
RECRUITING
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Fujian Medical University Union Hospital
The First Affiliated Hospital of Anhui Medical University
Conditions:
Mantle Cell Lymphoma (MCL)
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief Summary
This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients...
Eligibility Criteria
Inclusion
- Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
- Age \> 14 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.
- 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.
- Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 \> 30%, TP53 abnormality, blastic or pleomorphic variation.
- 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 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07199296
Start Date
July 1 2025
End Date
July 1 2028
Last Update
September 30 2025
Active Locations (1)
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1
Ruijin Hospital
Shanghai, China, 200025