A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
- Conditions
- Treatment-naїve Mantle Cell Lymphoma
- Interventions
- Drug: R-CHOP
- Registration Number
- NCT05051891
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 356
- 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
- Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
- No previous systemic treatment for MCL.
- ECOG physical strength score is 0-2.
- Expected survival time >6 months.
- Voluntary written informed consent prior to screening.
- Uncontrolled or significant cardiovascular diseases
- History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
- Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
- Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
- Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the experimental group Orelabrutinib and R-CHOP Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) The control group R-CHOP R-CHOP
- Primary Outcome Measures
Name Time Method PFS Up to 6 years To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).
- Secondary Outcome Measures
Name Time Method ORR Up to 6 years Objective Response Rate
CRR Up to 6 years Complete Response Rate
OS Up to 6 years Overall Survival
Trial Locations
- Locations (22)
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Henan Tumor Hospital
🇨🇳Zhengzhou, Henan, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaojing, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
Tumor in Hunan Province
🇨🇳Hunan, Changsha, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Anhui Province Cancer Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Guangxi, Nanning, China
Wuhan Union Hospital
🇨🇳Wuhan, Hubei, China
Hospital of Hematology, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
he First Affiliated Hospital of Zhengjiang University
🇨🇳Hangzhou, Zhejiang, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China