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
1 other identifier
interventional
3
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2021
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 21, 2021
CompletedStudy Start
First participant enrolled
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMarch 31, 2026
August 1, 2022
3.5 years
September 15, 2021
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
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).
Up to 6 years
Secondary Outcomes (3)
ORR
Up to 6 years
CRR
Up to 6 years
OS
Up to 6 years
Study Arms (2)
the experimental group
EXPERIMENTALOrelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
The control group
EXPERIMENTALR-CHOP
Interventions
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Eligibility Criteria
You may qualify if:
- \< 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Anhui Province Cancer Hospital
Hefei, Anhui, 230009, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100143, China
Tumor in Hunan Province
Hunan, Changsha, 410013, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011, China
Henan Tumor Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 3300008, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaojing, 110001, China
The First Affiliated Hospital of Guangxi Medical University
Guangxi, Nanning, 530021, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300052, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
he First Affiliated Hospital of Zhengjiang University
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 21, 2021
Study Start
December 22, 2021
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
March 31, 2026
Record last verified: 2022-08