Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
NCT ID: NCT06496308
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
78 participants
INTERVENTIONAL
2024-07-10
2027-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orelabrutinib + Bendamustine + Rituximab (OBR)
In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in OBR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, and orelabrutinib 150mg/day PO once daily, every 28 day per cycle for 6 cycles.
Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Bendamustine
Bendamustine IV will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV will be administered as per the schedule specified in the respective arm.
Bendamustine + Rituximab (BR)
In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in BR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, every 28 day per cycle for 6 cycles.
Bendamustine
Bendamustine IV will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV will be administered as per the schedule specified in the respective arm.
Orelabrutinib + Venetoclax (OV)
In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients with TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily and venetoclax for up to 2 years, the dosing of Venetoclax is escalated gradually to reach a target dose of 400 mg.
Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Venetoclax
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Orelabrutinib (O)
In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients without TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily for up to 2 years.
Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Interventions
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Orelabrutinib
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
Bendamustine
Bendamustine IV will be administered as per the schedule specified in the respective arm.
Rituximab
Rituximab IV will be administered as per the schedule specified in the respective arm.
Venetoclax
Venetoclax PO will be administered as per the schedule specified in the respective arm.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Third Xiangya Hospital of Central South University
UNKNOWN
Anhui Provincial Cancer Hospital
OTHER
Fujian Medical University Union Hospital
OTHER
Yantai Yuhuangding Hospital
OTHER
Huadong Hospital Affiliated with Fudan University, Shanghai
UNKNOWN
The First Affiliated Hospital of Anhui Medical University
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director, Hematology Department
Locations
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Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ORDER
Identifier Type: -
Identifier Source: org_study_id
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