Combining Orelabrutinib with Bendamustine and Rituximab for treating Mantle Cell Lymphoma
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 study is testing if adding Orelabrutinib to the standard treatment of Bendamustine and Rituximab can help people with intermediate- to high-risk mantle cell lymphoma who can't have a transplant feel better and live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | Rituximab, Orelabrutinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06496308 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, randomized controlled trial evaluates the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab compared to Bendamustine and Rituximab alone in patients with intermediate- to high-risk mantle cell lymphoma who are not eligible for transplantation. The primary goal is to assess the complete response rate during the induction phase, while secondary objectives include progression-free survival, overall survival, and safety. Additionally, the study will explore the correlation between tumor biomarkers and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with untreated mantle cell lymphoma and specific high-risk factors who are not suitable for autologous stem cell transplantation.
Not a fit: Patients with low-risk mantle cell lymphoma or those who have received prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could improve response rates and survival outcomes for patients with mantle cell lymphoma.
How similar studies have performed: Other studies have shown promising results with similar treatment combinations in hematologic malignancies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weili Zhao
- Email: zhao.weili@yahoo.com
- Phone: +862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.