Clinical trial NCT05051891: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Treatment-naїve Mantle Cell Lymphoma
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 356
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
2. 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.
3. No previous systemic treatment for MCL.
4. ECOG physical strength score is 0-2.
5. Expected survival time \>6 months.
6. Voluntary written informed consent prior to screening.

Exclusion Criteria:

1. Uncontrolled or significant cardiovascular diseases
2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
5. 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.

Primary outcomes:
measure: PFS
timeFrame: Up to 6 years
Secondary outcomes:
measure: ORR
timeFrame: Up to 6 years
measure: CRR
timeFrame: Up to 6 years
measure: OS
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Province Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Hunan
country: China
facility: Tumor in Hunan Province
state: Changsha
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Tumor Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaojing
city: Guangxi
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Nanning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Hospital of Hematology, Chinese Academy of Medical Sciences
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: he First Affiliated Hospital of Zhengjiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: