Trial Title:
Evaluating Different Doses of Orelabrutinib in MCL
NCT ID:
NCT05978739
Condition:
Mantle Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib High dose
Description:
Orelabrutinib will be administered as 3 tablets once per day
Arm group label:
Orelabrutinib high dose
Intervention type:
Drug
Intervention name:
Orelabrutinib Low dose
Description:
Orelabrutinib will be administered as 1 tablet once per day
Arm group label:
Orelabrutinib low dose
Summary:
This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different
Doses of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in
Mantle Cell Lymphoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male and female subjects ≥ 18 years of age.
2. Mantle cell lymphoma (MCL) confirmed by histopathology.
3. Subjects who have not previously received standard systemic care and
relapsing/refractory subjects who have previously received standard systemic care.
4. At least one measurable lesion.
5. ECOG Physical fitness score 0-2 points.
6. Expected survival time ≥ 4 months.
7. Full hematology function.
8. Blood clotting function is basically normal.
9. Subjects with basically normal liver, kidney and heart function.
10. Subject voluntarily signs a written ICF.
11. The serum pregnancy test of female subjects with fertility potential was negative
within 7 days before the first dosing.
12. Female subjects with reproductive potential or male subjects and their partners must
agree to use effective contraception for at least 6 months from signing the ICF
until the last dose of the study drug.
Exclusion Criteria:
1. Adequate treatment with BTK inhibitors.
2. Have a history of severe allergic disease and a history of severe drug allergy.
3. Subjects who have received the treatment or drug restricted in the protocol within
the time specified for the first use of the investigational drug.
4. The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food,
western medicine, and Chinese medicine) was less than 2 weeks (or less than 5
half-lives, depending on the time) from the first trial, or plan to take a potent
CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.
5. History of other active malignant diseases within 2 years prior to screening.
6. Subjects with systemic bacterial, viral, fungal (other than nail fungal infections)
or parasitic infections with poorly controlled activity.
7. Indicates active hepatitis B or C virus infection.
8. There are diseases that are excluded from the criteria in the programme.
9. Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study
therapy (according to CTCAE V5.0).
10. History of severe bleeding disorder.
11. People with a known history of alcohol or drug abuse.
12. Subjects with mental disorders or poor compliance.
13. Pregnant or lactating female subjects.
14. Other conditions deemed unsuitable for participation in this study by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233040
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanli Yang
Facility:
Name:
The First Affiliated Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qingshu Zeng
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongmei Jing
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Jieping Li
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangdong
Zip:
510055
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Li
Facility:
Name:
Nanyang Second General Hospital
Address:
City:
Nanyang
Zip:
473009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jinxiao Yao
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihua Yao
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Zhang
Facility:
Name:
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Guohui Cui
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Huijing Wu
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Zhou
Facility:
Name:
Chenzhou First People's Hospital
Address:
City:
Chenzhou
Zip:
423003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinquan Liang
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Yu
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wuping Li
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116023
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiuhua Sun
Facility:
Name:
The First Affiliated Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojing Yan
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liping Su
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianli Wang
Facility:
Name:
The Affiliated Cancer Hospital of Xinjiang Medical University
Address:
City:
Urumqi
Zip:
830000
Country:
China
Status:
Recruiting
Contact:
Last name:
Shujuan Wen
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenjuan Yu
Start date:
August 18, 2023
Completion date:
May 25, 2025
Lead sponsor:
Agency:
InnoCare Pharma Inc.
Agency class:
Industry
Collaborator:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
InnoCare Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978739
