Clinical trial · Interventional
Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) | Drug | — | UNRESOLVED |
| Orelabrutinib | Drug | — | UNRESOLVED |
| orelabrutinib maintenance | Drug | — | UNRESOLVED |
| Rituximab (R) | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Orelabrutinib + Rituximab +/- ASCT and Orelabrutinib Maintenance
- description
- 1. In induction phase, patients will receive rituximab 375 mg/m² IV on day 1,8,15,22 in Cycle 1, then day 1/cycle, and orelabrutinib 150 mg/day PO once daily, every 28 day per cycle for 6 cycles. Patients with an objective response (complete or partial) after induction therapy, who meet ASCT eligibility criteria and consent, proceed to transplantation. 2. ASCT: BEAM pretreatment. Patients receive carmustine on day -7, etoposide on days -6-(-3), cytarabine on days -6-(-3) and melphalan on day -2. 3. In maintenance phase, patients will recieve orelabrutinib 150 mg/day PO once daily until disease progression or intolerable toxicity.
- interventionNames
- Drug: Orelabrutinib
- Drug: Rituximab (R)
- Drug: BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan)
- Drug: orelabrutinib maintenance
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (0)
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