Back to resultsA 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
Primary Purpose
Treatment-naїve Mantle Cell Lymphoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Orelabrutinib and R-CHOP
R-CHOP
Sponsored by
About this trial
This is an interventional treatment trial for Treatment-naїve Mantle Cell Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Anhui Province Cancer Hospital
- Beijing Cancer HospitalRecruiting
- Tumor in Hunan Province
- The First Affiliated Hospital of Xiamen University
- Sun Yat-sen University Cancer Center
- Guangzhou First People's Hospital
- The Fourth Hospital of Hebei Medical University
- Henan Tumor Hospital
- The First Affiliated Hospital of Zhengzhou University
- Wuhan Union Hospital
- Jiangsu Province Hospital
- The First Affiliated Hospital of Soochow University
- The First Affiliated Hospital of Nanchang University
- The First Hospital of Jilin University
- The First Hospital of China Medical University
- The First Affiliated Hospital of Guangxi Medical University
- Shandong Provincial Hospital
- West China Hospital,Sichuan University
- Hospital of Hematology, Chinese Academy of Medical Sciences
- Tianjin Cancer Hospital
- he First Affiliated Hospital of Zhengjiang University
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
the experimental group
The control group
Arm Description
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
R-CHOP
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
ORR
Objective Response Rate
CRR
Complete Response Rate
OS
Overall Survival
Full Information
NCT ID
NCT05051891
First Posted
September 15, 2021
Last Updated
October 10, 2022
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05051891
Brief 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
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment-naїve Mantle Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the experimental group
Arm Type
Experimental
Arm Description
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Arm Title
The control group
Arm Type
Experimental
Arm Description
R-CHOP
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib and R-CHOP
Intervention Description
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Intervention Type
Drug
Intervention Name(s)
R-CHOP
Intervention Description
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Primary Outcome Measure Information:
Title
PFS
Description
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).
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response Rate
Time Frame
Up to 6 years
Title
CRR
Description
Complete Response Rate
Time Frame
Up to 6 years
Title
OS
Description
Overall Survival
Time Frame
Up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April Huang
Phone
010-66609723
Email
April.huang@innocarepharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Zhao
Email
Xinghua.zhao@innocarepharma.com
Facility Information:
Facility Name
Anhui Province Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiyang Ding
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100143
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu
Facility Name
Tumor in Hunan Province
City
Hunan
State/Province
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhou
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifeng Li
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Li
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Li
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Liu
Facility Name
Henan Tumor Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keshu Zhou
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohui Cui
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depei Wu
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
3300008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ou Bai
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaojing
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Yang
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Guangxi
State/Province
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhigang Peng
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Niu
Facility Name
Hospital of Hematology, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhua Yi
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huilai Zhang
Facility Name
he First Affiliated Hospital of Zhengjiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Yang
12. IPD Sharing Statement
Learn more about this trial
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
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