Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
Recruiting now · Phase 2
Conditions studied: Mantle Cell Lymphoma (MCL)
In brief
This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with 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.
Key facts
- Study ID
- NCT07272499
- Run by
- Ruijin Hospital
- People needed
- 25
- Starts
- 2025-09-10
- Expected to finish
- 2028-09-10
- Last updated by the study team
- 2026-07-28
Who can join
Age: 14 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 > 30%, TP53 mutation/loss or p53 protein expression >50%, blastic or pleomorphic variation.
- 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.
You may not qualify if…
- 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 it is running
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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