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

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05051891

Collaborator

(none)

356

Enrollment

Locations

Arms

72.3

Anticipated Duration (Months)

16.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment-naїve Mantle Cell Lymphoma	Drug: Orelabrutinib and R-CHOP Drug: R-CHOP	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

356 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 22, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the experimental group Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)	Drug: Orelabrutinib and R-CHOP Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Experimental: The control group R-CHOP	Drug: R-CHOP Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Arm

Intervention/Treatment

Experimental: the experimental group

Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Drug: Orelabrutinib and R-CHOP

Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Experimental: The control group

R-CHOP

Drug: R-CHOP

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Outcome Measures

Primary Outcome Measures

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

ORR [Up to 6 years]
Objective Response Rate
CRR [Up to 6 years]
Complete Response Rate
OS [Up to 6 years]
Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Province Cancer Hospital	Hefei	Anhui	China	230009
2	Beijing Cancer Hospital	Beijing	Beijing	China	100143
3	Tumor in Hunan Province	Hunan	Changsha	China	410013
4	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361003
5	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
6	Guangzhou First People's Hospital	Guangzhou	Guangdong	China	510180
7	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	50011
8	Henan Tumor Hospital	Zhengzhou	Henan	China	450008
9	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
10	Wuhan Union Hospital	Wuhan	Hubei	China	430022
11	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
12	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
13	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China	3300008
14	The First Hospital of Jilin University	Changchun	Jilin	China	130021
15	The First Hospital of China Medical University	Shenyang	Liaojing	China	110001
16	The First Affiliated Hospital of Guangxi Medical University	Guangxi	Nanning	China	530021
17	Shandong Provincial Hospital	Jinan	Shandong	China	250021
18	West China Hospital,Sichuan University	Chengdu	Sichuan	China	610041
19	Hospital of Hematology, Chinese Academy of Medical Sciences	Tianjin	Tianjin	China	300052
20	Tianjin Cancer Hospital	Tianjin	Tianjin	China	300060
21	he First Affiliated Hospital of Zhengjiang University	Hangzhou	Zhejiang	China	310003
22	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022