A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Registration Number
- NCT06363994
- Lead Sponsor
- InnoCare Pharma Inc.
- Brief Summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 476
- Subjects β₯ 65 of age, or β₯ 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Orelabrutinib - Arm A Bendamustine Injection - Arm A Rituximab - Arm B Bendamustine Injection - Arm B Rituximab - Arm B Orelabrutinib Placebo -
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) 28 days Progression-free Survival (PFS) for Arm A vs. Arm B Approximately 7 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
Fujing Cancer Hospital
π¨π³Fuzhou, China
Beijing Cancer Hospital
π¨π³Beijing, China
Peking University Third Hospital
π¨π³Beijing, China
The First Affiliated Hospital of Bengbu Medical University
π¨π³Bengbu, China
First Hospital of Jilin University
π¨π³Changchun, China
Hunan Cancer Hospital
π¨π³Changsha, China
The First People's Hospital of Changzhou
π¨π³Changzhou, China
Sichuan Provincial People's Hospital
π¨π³Chengdu, China
West China Hospital of Sichuan University
π¨π³Chengdu, China
Chongqinq Cancer Hospital
π¨π³Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, China
The second Hospital of Dalian Medical University
π¨π³Dalian, China
Union Hospital Affiliated to Fujian Medical University
π¨π³Fuzhou, China
Guangdong Provincial People's Hospital
π¨π³Guangzhou, China
Sun Yat-sen University Cancer Center
π¨π³Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
π¨π³Hangzhou, China
Zhejiang University Medical School affiliated to the first Hospital
π¨π³Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
π¨π³Hefei, China
Shandong Provincial Hospital
π¨π³Jinan,, China
Cancer Hospital of Shandong First Medical University
π¨π³Jinan, China
The First Affiliated Hospital of Ningbo University
π¨π³Jinan, China
The First Affiliated Hospital of Henan University of Science & Technology
π¨π³Luoyang, China
The First Affiliated Hospital of Nanchang University
π¨π³Nanchang, China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
π¨π³Nanjing, China
Cancer Hospital Affiliated to Fudan University
π¨π³Shanghai, China
Huashan Hospital of Fudan University
π¨π³Shanghai, China
Shengjing Hospital of China Medical University
π¨π³Shenyang, China
The First Affiliated Hospital of China Medical University
π¨π³Shenyang, China
The Fourth Hospital of Hebei Medical University
π¨π³Shijiazhuang, China
Shanxi Cancer Hospital
π¨π³Taiyuan, China
Tianjin Cancer Hospital
π¨π³Tianjin, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
π¨π³Wuhan, China
The Tumor Hospital Affiliated to Xinjiang Medical University
π¨π³Wulumuqi, China
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
π¨π³Xi'an, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
π¨π³Xi'an, China
Yibin Second People's Hospital
π¨π³Yibin, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Henan Provincial People's Hospital
π¨π³Zhengzhou, China