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)
Ruijin Hospital
45 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria8
- 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.
Interventions
orelabrutinib 150mg/day PO once daily
rituximab 375 mg/m² IV on day 1, 8, 15, 22 in Cycle 1, then day 1/cycle
the reference doses are as follows (each center may adjust them as appropriate based on actual conditions): carmustine 300mg/m² IV d-1; etoposide 200mg/m² IV d-6-(-3); cytarabine 200mg/m² IV d-6-(-3); melphalan 140mg/m² IV d-2.
orelabrutinib 150mg/day PO once daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07199296