Tests orelabrutinib with rituximab for mantle cell lymphoma
Tests orelabrutinib with rituximab in people with a newly diagnosed mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Where in China
- Ruijin hospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07199296
- Record updated
- 30 September 2025
- Original description
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 with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.Read full original descriptionShow less
A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib in Combination With Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in Treatment-Naive, Non-High-Risk Mantle Cell Lymphoma (MCL)
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 with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.
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; 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; Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 > 30%, TP53 abnormality, blastic or pleomorphic variation.