A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
1 other identifier
interventional
476
1 country
39
Brief Summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2024
Longer than P75 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
April 12, 2024
CompletedStudy Start
First participant enrolled
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 25, 2032
December 27, 2024
December 1, 2024
7.1 years
April 9, 2024
December 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicity (DLT)
28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
Approximately 7 years
Study Arms (2)
Arm A
ACTIVE COMPARATORArm B
ACTIVE COMPARATORInterventions
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Eligible patients will receive Bendamustine by injection as per the protocol
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Eligibility Criteria
You may qualify if:
- Subjects ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
- Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
- Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
- At least one measurable site of disease (the longest axis of the lymph node lesion is \> 1.5 cm, or the longest diameter of the extranodal lesion is \> 1.0 cm).
- ECOG PS score of 0 to 2.
You may not qualify if:
- Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
- Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
- Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
- Known central nervous system lymphoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
The First People's Hospital of Changzhou
Changzhou, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqinq Cancer Hospital
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The second Hospital of Dalian Medical University
Dalian, China
Fujing Cancer Hospital
Fuzhou, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang University Medical School affiliated to the first Hospital
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Shandong Provincial Hospital
Jinan, China
The First Affiliated Hospital of Ningbo University
Jinan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, China
Cancer Hospital Affiliated to Fudan University
Shanghai, China
Huashan Hospital of Fudan University
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of China Medical University
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Cancer Hospital
Taiyuan, China
Tianjin Cancer Hospital
Tianjin, China
The Tumor Hospital Affiliated to Xinjiang Medical University
Ürümqi, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, China
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xi'an, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, China
Yibin Second People's Hospital
Yibin, China
Henan Cancer Hospital
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2024
First Posted
April 12, 2024
Study Start
May 29, 2024
Primary Completion (Estimated)
June 25, 2031
Study Completion (Estimated)
June 25, 2032
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share