Tests orelabrutinib with standard chemotherapy in newly diagnosed mantle cell lymphoma
Tests orelabrutinib added to standard treatment in adults newly diagnosed with mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Key facts
- Where
- Beijing, Bengbu, Changchun, Changsha, Changzhou, Chengdu, Chongqing, Dalian, Fuzhou, Guangzhou, Hangzhou, Hefei, Jinan, Luoyang, Nanchang, Nanjing, Shanghai, Shenyang, Shijiazhuang, Taiyuan, Tianjin, Ürümqi, Wuhan, Xi'an, Yibin, and Zhengzhou, ChinaSee the 38 sites
- Phase
- Phase 3
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- Peking University Third HospitalBeijing, ChinaTaking people
- The First Affiliated Hospital of Bengbu Medical UniversityBengbu, ChinaTaking people
- First Hospital of Jilin UniversityChangchun, ChinaNot yet recruiting
- Hunan Cancer HospitalChangsha, ChinaTaking people
- The First People's Hospital Of ChangzhouChangzhou, ChinaNot yet recruiting
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaNot yet recruiting
- Chongqinq Cancer HospitalChongqing, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
- The Second Hospital of Dalian Medical UniversityDalian, ChinaNot yet recruiting
- Fujing Cancer HospitalFuzhou, ChinaTaking people
- Union Hospital Affiliated to Fujian Medical UniversityFuzhou, ChinaNot yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- The Second Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaNot yet recruiting
- Zhejiang University Medical School affiliated to the first HospitalHangzhou, ChinaTaking people
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
- Cancer Hospital of Shandong First Medical UniversityJinan, ChinaNot yet recruiting
- Shandong Provincial HospitalJinan, ChinaNot yet recruiting
- The First Affiliated Hospital of Ningbo UniversityJinan, ChinaTaking people
- The First Affiliated Hospital of Henan University of Science &TechnologyLuoyang, ChinaNot yet recruiting
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing UniversityNanjing, ChinaNot yet recruiting
- Cancer Hospital Affiliated to Fudan UniversityShanghai, ChinaNot yet recruiting
- Huashan Hospital of Fudan UniversityShanghai, ChinaTaking people
- Shengjing Hospital Of China Medical UniversityShenyang, ChinaNot yet recruiting
- The First Affiliated Hospital of China Medical UniversityShenyang, ChinaTaking people
- The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaNot yet recruiting
- Shanxi Cancer hospitalTaiyuan, ChinaNot yet recruiting
- Tianjin Cancer HospitalTianjin, ChinaTaking people
- The Tumor Hospital Affiliated to Xinjiang Medical UniversityÜrümqi, ChinaTaking people
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science andWuhan, ChinaTaking people
- The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)Xi'an, ChinaNot yet recruiting
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNot yet recruiting
- Yibin Second People's HospitalYibin, ChinaNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- InnoCare Pharma Inc.
- Trial code
- NCT06363994EU 2025-524241-27-00
- Record updated
- 27 December 2024
- Original description
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)Read full original descriptionShow less
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
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Inclusion: 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.
Exclusion: 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; Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening; Known central nervous system lymphoma.