Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
ConditionMantle Cell Lymphoma (MCL)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital
About this trial
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the 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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Orelabrutinib
- Bendamustine
- Rituximab
- Venetoclax
Treatment groups
78 Participants
are divided into 4 treatment groupsSponsors and collaborators
Ruijin Hospital
Lead sponsor
The Third Xiangya Hospital of Central South University
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
Yantai Yuhuangding Hospital
Collaborator
Huadong Hospital Affiliated with Fudan University, Shanghai
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Source ClinicalTrials.gov