Trial Title:
A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
NCT ID:
NCT06566586
Condition:
B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3702 tablets+Chemotherapy regimen
Description:
TQB3702 tablets: Tyrosine kinase inhibitor；
Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis,
inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis；
Arm group label:
TQB3702 tablets+Chemotherapy regimen
Summary:
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy
for the treatment of B-cell lymphoma
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- The subjects voluntarily joined the study, signed the informed consent, and the
compliance was good;
- Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Eastern
cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3
months;
- Histologically confirmed B-cell lymphomas of the following types that meet the 2022
World Health Organization (WHO) diagnostic criteria:
1. Relapsed/refractory indolent B-cell lymphoma
2. Diffuse large B cell lymphoma（DLBCL）
- Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at
least one previous line of systemic standard therapy
- Have at least one measurable lesion.
- The main organs function well.
- Female subjects of reproductive age should agree to use contraception (such as Iuds,
contraceptives, or condoms) during the study period and for 6 months after the end
of the study; Have a negative serum pregnancy test within 7 days prior to study
enrollment and must be a non-lactating subject; Male subjects should agree to use
avoidance during the study period and for 6 months after the end of the study
period.
Exclusion Criteria:
- Have had or are currently suffering from other malignant tumors within 3 years prior
to the first medication.
- Known or suspected central nervous system (CNS) aggression.
- Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem
cell transplantation, or autologous hematopoietic stem cell transplantation within 3
months before the first treatment;
- Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to
≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1
due to any previous treatment, excluding hair loss and fatigue;
- Have multiple factors that affect oral drug absorption (such as inability to
swallow, chronic diarrhea, and intestinal obstruction);
- Received major surgical treatment or significant traumatic injury within 28 days
before the start of study treatment;
- Hyperkinetic/venous thrombosis events occurred within 6 months before the first
medication;
- Have a history of psychotropic drug abuse and can not quit or have mental disorders;
- Subjects with any severe and/or uncontrolled disease;
- Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks
before the first dose, or planned to receive live vaccine or mRNA vaccine during the
study;
- Participated in clinical trials of other antitumor drugs within 4 weeks before the
first medication;
- Subjects who, in the judgment of the investigator, have concomitant diseases that
seriously endanger the safety of the subjects or affect the completion of the study,
or subjects who are not suitable for enrollment for other reasons.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinise Academy of Medical Sciences
Address:
City:
BeiJing
Zip:
100021
Country:
China
Contact:
Last name:
Peng Liu, Doctor
Phone:
13910216310
Email:
13910216310@163.com
Facility:
Name:
Gansu Provincial Cancer Hospital
Address:
City:
Lanzhou
Zip:
730000
Country:
China
Contact:
Last name:
Junfeng Jiang, Doctor
Phone:
13893332604
Email:
13893332604@163.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Hua Wang, Doctor
Phone:
15920352412
Email:
wanghua@sysucc.org.cn
Facility:
Name:
Guigang City People's Hospital
Address:
City:
Guigang
Zip:
537000
Country:
China
Contact:
Last name:
Yi Huang, Bachelor
Phone:
15977590866
Email:
huangyi236@126.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Contact:
Last name:
Hong Cen, Doctor
Phone:
13507711671
Email:
cen_hong@163.com
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Contact:
Last name:
Xiaohong Tan, Doctor
Phone:
13877193237
Email:
tanxhong@163.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Contact:
Last name:
Qingyuan Zhang, Doctor
Phone:
13313612989
Email:
sy86298276@163.com
Facility:
Name:
PuYang AnYang District Hospital
Address:
City:
Anyang
Zip:
450000
Country:
China
Contact:
Last name:
Junxia Meng, Bachelor
Phone:
13526194738
Email:
3086256729@qq.com
Facility:
Name:
Puyang People's Hospital
Address:
City:
Puyang
Zip:
457000
Country:
China
Contact:
Last name:
Zhichun Li, Master
Phone:
13839313232
Email:
13839313232@163.com
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Zunmin Zhu, Doctor
Phone:
13603712008
Email:
zhuzm1964@163.com
Facility:
Name:
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
457000
Country:
China
Contact:
Last name:
Keshu Zhou, Master
Phone:
13674902391
Email:
drzhouks77@163.com
Facility:
Name:
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Address:
City:
Wuhan
Zip:
430022
Country:
China
Contact:
Last name:
Fang Zhu, Doctor
Phone:
13871545106
Email:
zhufang1226@126.com
Facility:
Name:
Tongji Hospital Tongji Medical College of HUST
Address:
City:
Wuhan
Zip:
430030
Country:
China
Contact:
Last name:
Yi Xiao, Doctor
Phone:
13036120269
Email:
yixiao@tjmu.tjh.edu.cn
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
XiangYang
Zip:
441000
Country:
China
Contact:
Last name:
Quan Li, Doctor
Phone:
13972099899
Email:
124993699@qq.com
Facility:
Name:
Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
Yajun Li, Doctor
Phone:
18273175031
Email:
liyajun@hnca.org.cn
Facility:
Name:
Zhuzhou Central Hospital
Address:
City:
Zhuzhou
Zip:
412000
Country:
China
Contact:
Last name:
Chanjuan Shen, Master
Phone:
18973389928
Email:
Shenchanjuan@163.com
Facility:
Name:
The Affiliated Hospital of Inner Mongolia Medical University
Address:
City:
Hohhot
Zip:
10000
Country:
China
Contact:
Last name:
Da Gao, Master
Phone:
13947130473
Email:
Gaoda72@163.com
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Contact:
Last name:
Lei Fan, Doctor
Phone:
13813976136
Email:
fanlei3014@126.com
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Contact:
Last name:
Fei Li, Doctor
Phone:
13970038386
Email:
yx021021@sina.com
Facility:
Name:
The second Hospital of dalian
Address:
City:
Dalian
Zip:
116000
Country:
China
Contact:
Last name:
Xiuhua Sun, Master
Phone:
17709873631
Email:
3038668@vip.sina.com
Facility:
Name:
The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
Address:
City:
Xi'an
Zip:
710004
Country:
China
Contact:
Last name:
Wanhong Zhao, Doctor
Phone:
18991908852
Email:
13991365406@163.com
Facility:
Name:
Affiliated Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Zengjun Li, Doctor
Phone:
13642138692
Email:
zengjunli@163.com
Facility:
Name:
Tai'an Central Hospital
Address:
City:
Tai'an
Zip:
271000
Country:
China
Contact:
Last name:
Ling Wang, Doctor
Phone:
13583897631
Email:
13583897631@163.com
Facility:
Name:
Tongji Hospital of Tongji University
Address:
City:
Shanghai
Zip:
200063
Country:
China
Contact:
Last name:
Ping Li, Doctor
Phone:
13564181131
Email:
Lilyforever76@126.com
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
TaiYuan
Zip:
030000
Country:
China
Contact:
Last name:
Liping Su, Doctor
Phone:
13835158122
Email:
slpsy2022@163.com
Facility:
Name:
The Affiliated Hospital of Southwest Medical University
Address:
City:
Luzhou
Zip:
646000
Country:
China
Contact:
Last name:
XiaoMing Li, Master
Phone:
13700986866
Email:
Lxm6358@21cn.com
Facility:
Name:
Zigong First People's Hospital
Address:
City:
Zigong
Zip:
643000
Country:
China
Contact:
Last name:
Jian Xiao, Master
Phone:
15881327002
Email:
16188702@qq.com
Facility:
Name:
Tianjin People's Hospital
Address:
City:
Tianjin
Zip:
300122
Country:
China
Contact:
Last name:
Huaqing Wang, Doctor
Phone:
18622221223
Email:
wanghuaqing@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300202
Country:
China
Contact:
Last name:
Shiyong Zhou, Doctor
Phone:
13820041468
Email:
Zsy1003@163.com
Facility:
Name:
Affiliated Tumor Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830000
Country:
China
Contact:
Last name:
Shujuan Wen, Doctor
Phone:
18160631686
Email:
736587502@qq.com
Start date:
October 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06566586
