Tests orelabrutinib added to standard treatment for mantle cell lymphoma
Tests orelabrutinib with standard treatment in adults with mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06496308, who can take part
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
- NCT06496308
- Record updated
- 11 July 2024
- Original description
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 Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the 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 Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)
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 Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the 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 > 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.