The First Affiliated Hospital of Anhui Medical University
The Third Xiangya Hospital of Central South University
First Affiliated Hospital of Wenzhou Medical University
Qilu Hospital of Shandong University
Huadong Hospital
Age
14–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment