Orelabrutinib with rituximab and optional autologous stem cell transplant for mantle cell lymphoma
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 phase 2 trial tests whether adding the oral BTK inhibitor orelabrutinib to rituximab, with optional autologous stem cell transplant and orelabrutinib maintenance, works and is safe for people with newly diagnosed non-high-risk mantle cell lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | rituximab, orelabrutinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07199296 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label phase 2 trial gives treatment-naïve patients orelabrutinib plus rituximab during an induction phase; responders may proceed to optional autologous hematopoietic stem cell transplantation followed by orelabrutinib maintenance. The primary endpoint is the complete response (CR) rate during induction, with secondary endpoints including progression-free survival, overall survival, objective response rate, and safety. Conditioning with BEAM is used for patients who undergo transplant. Exploratory biomarker analyses will examine correlations between tumor markers and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve patients older than 14 with biopsy-confirmed, measurable stage II–IV non-high-risk mantle cell lymphoma, adequate blood, liver and kidney function, and expected survival beyond 12 weeks.
Not a fit: Patients with high-risk MCL features, prior systemic therapy, significant organ dysfunction, or inability to attend site visits or undergo transplant procedures are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, this approach could raise complete response rates and prolong time without progression while offering an oral maintenance option that may delay or reduce need for more intensive therapies.
How similar studies have performed: Other studies combining BTK inhibitors (like ibrutinib) with anti-CD20 antibodies have shown promising activity in MCL, but orelabrutinib-specific data and this exact combination with optional transplant remain relatively limited.
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 \> 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 Criteria: * 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.
Where this trial is running
Shanghai
- Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Li Wang
- Email: wl11194@rjh.com.cn
- Phone: +862164370045 ext 610707
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.