NCT06496308 Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
| NCT ID | NCT06496308 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ruijin Hospital |
| Condition | Mantle Cell Lymphoma (MCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2027-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 78 participants in total. It began in 2024-07-10 with a primary completion date of 2027-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06496308 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Mantle Cell Lymphoma (MCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06496308 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 78 participants.
Is NCT06496308 currently recruiting?
Yes, NCT06496308 is actively recruiting participants. Contact the research team at zhao.weili@yahoo.com for enrollment information.
Where is the NCT06496308 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06496308 clinical trial?
NCT06496308 is sponsored by Ruijin Hospital. The trial plans to enroll 78 participants.