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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Orelabrutinib
DrugOrelabrutinib PO will be administered as per the schedule specified in the respective arm.
Bendamustine
DrugBendamustine IV will be administered as per the schedule specified in the respective arm.
Rituximab
DrugRituximab IV will be administered as per the schedule specified in the respective arm.
Venetoclax
DrugVenetoclax PO will be administered as per the schedule specified in the respective arm.
Treatment groups
78 Participants
are divided into 4 treatment groupsGroup A: Orelabrutinib + Bendamustine + Rituximab (OBR)Experimental treatment 3 interventions
Group B: Bendamustine + Rituximab (BR)Placebo comparator 2 interventions
Group C: Orelabrutinib + Venetoclax (OV)Other 2 interventions
Group D: Orelabrutinib (O)Other 1 intervention
Trial outcomes
Primary outcomes
1
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame
End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]Secondary outcomes
1
Overall Response Rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame
End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]2
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame
Baseline up to data cut-off (up to approximately 2 years)3
Overall survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time frame
Baseline up to data cut-off (up to approximately 2 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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