Mantle Cell Lymphoma (MCL)
Conditions
Brief 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.
Interventions
DRUGOrelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
DRUGBendamustine
Bendamustine IV will be administered as per the schedule specified in the respective arm.
DRUGRituximab
Rituximab IV will be administered as per the schedule specified in the respective arm.
DRUGVenetoclax
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Sponsors
The Third Xiangya Hospital of Central South University
Anhui Provincial Cancer Hospital
Fujian Medical University Union Hospital
Yantai Yuhuangding Hospital
Huadong Hospital Affiliated with Fudan University, Shanghai
The First Affiliated Hospital of Anhui Medical University
Jiangxi Provincial Cancer Hospital
Fujian Cancer Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days] | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days] | Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria. |
| Progression-free survival | Baseline up to data cut-off (up to approximately 2 years) | 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. |
| Overall survival | Baseline up to data cut-off (up to approximately 2 years) | Overall survival was defined as the time from the date of randomization to the date of death from any cause. |
Countries
China
Contacts
Primary ContactWeili Zhao
Backup ContactLi Wang
Outcome results
None listed