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Trial Title:
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
NCT ID:
NCT06496308
Condition:
Mantle Cell Lymphoma (MCL)
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Venetoclax
Bendamustine Hydrochloride
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Orelabrutinib PO will be administered as per the schedule specified in the respective
arm.
Arm group label:
Orelabrutinib (O)
Arm group label:
Orelabrutinib + Bendamustine + Rituximab (OBR)
Arm group label:
Orelabrutinib + Venetoclax (OV)
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
Bendamustine IV will be administered as per the schedule specified in the respective arm.
Arm group label:
Bendamustine + Rituximab (BR)
Arm group label:
Orelabrutinib + Bendamustine + Rituximab (OBR)
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab IV will be administered as per the schedule specified in the respective arm.
Arm group label:
Bendamustine + Rituximab (BR)
Arm group label:
Orelabrutinib + Bendamustine + Rituximab (OBR)
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Arm group label:
Orelabrutinib + Venetoclax (OV)
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 >
50%, TP53 abnormality, blastic or pleomorphic variation.
- Patients who are not suitable candidates for autologous hematopoietic stem cell
transplantation.
- 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao
Phone:
13512112076
Email:
zhao.weili@yahoo.com
Start date:
July 10, 2024
Completion date:
July 10, 2027
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Third Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Medical University Union Hospital
Agency class:
Other
Collaborator:
Agency:
Yantai Yuhuangding Hospital
Agency class:
Other
Collaborator:
Agency:
Huadong Hospital Affiliated with Fudan University, Shanghai
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Anhui Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496308
