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Recruiting

A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

ClinicalTrials.gov ID NCT06566586
Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Information provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Responsible Party)
Last Update Posted 2024-11-20
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Study Overview

Brief Summary
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
Official Title
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
Conditions
B-cell Lymphoma
Intervention / Treatment
  • Drug: TQB3702 tablets+Chemotherapy regimen
  • Drug: TQB3702 tablets+Chemotherapy regimen
Other Study ID Numbers
  • TQB3702-II-02
Study Start (Actual)
2024-11-06
Primary Completion (Estimated)
2026-03
Study Completion (Estimated)
2027-12
Enrollment (Estimated)
80
Study Type
Interventional
Phase
Phase 2

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: Zengjun Li, Doctor

Phone Number: 13642138692

Email: zengjunli@163.com

Study Contact Backup

Name: Fei Li, Doctor

Phone Number: 13970038386

Email: yx021021@sina.com

This study has 30 locations
China
Beijing Locations
BeiJing, Beijing, China, 100021

Not yet recruiting

Cancer Hospital Chinise Academy of Medical Sciences
Contact:
Peng Liu, Doctor
13910216310
13910216310@163.com
Gansu Locations
Lanzhou, Gansu, China, 730000

Not yet recruiting

Gansu Provincial Cancer Hospital
Contact:
Junfeng Jiang, Doctor
13893332604
13893332604@163.com
Guangdong Locations
Guangzhou, Guangdong, China, 510000

Not yet recruiting

Sun Yat-sen University Cancer Center
Contact:
Hua Wang, Doctor
15920352412
wanghua@sysucc.org.cn
Guangxi Locations
Guigang, Guangxi, China, 537000

Not yet recruiting

Guigang City People's Hospital
Contact:
Yi Huang, Bachelor
15977590866
huangyi236@126.com
Nanning, Guangxi, China, 530021

Not yet recruiting

Guangxi Medical University Cancer Hospital
Contact:
Hong Cen, Doctor
13507711671
cen_hong@163.com
Nanning, Guangxi, China, 530021

Not yet recruiting

Guangxi Medical University Cancer Hospital
Contact:
Xiaohong Tan, Doctor
13877193237
tanxhong@163.com
Heilongjiang Locations
Harbin, Heilongjiang, China, 150000

Not yet recruiting

Harbin Medical University Cancer Hospital
Contact:
Qingyuan Zhang, Doctor
13313612989
sy86298276@163.com
Henan Locations
Anyang, Henan, China, 450000

Not yet recruiting

PuYang AnYang District Hospital
Contact:
Junxia Meng, Bachelor
13526194738
3086256729@qq.com
Puyang, Henan, China, 457000

Not yet recruiting

Puyang People's Hospital
Contact:
Zhichun Li, Master
13839313232
13839313232@163.com
Zhengzhou, Henan, China, 450000

Not yet recruiting

Henan Provincial People's Hospital
Contact:
Zunmin Zhu, Doctor
13603712008
zhuzm1964@163.com
Zhengzhou, Henan, China, 457000

Not yet recruiting

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Contact:
Keshu Zhou, Master
13674902391
drzhouks77@163.com
Hubei Locations
Wuhan, Hubei, China, 430022

Not yet recruiting

Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Contact:
Fang Zhu, Doctor
13871545106
zhufang1226@126.com
Wuhan, Hubei, China, 430030

Not yet recruiting

Tongji Hospital Tongji Medical College of HUST
Contact:
Yi Xiao, Doctor
13036120269
yixiao@tjmu.tjh.edu.cn
XiangYang, Hubei, China, 441000

Not yet recruiting

Xiangyang Central Hospital
Contact:
Quan Li, Doctor
13972099899
124993699@qq.com
Hunan Locations
Changsha, Hunan, China, 410013

Not yet recruiting

Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Contact:
Yajun Li, Doctor
18273175031
liyajun@hnca.org.cn
Zhuzhou, Hunan, China, 412000

Not yet recruiting

Zhuzhou Central Hospital
Contact:
Chanjuan Shen, Master
18973389928
Shenchanjuan@163.com
Inner Mongolia Locations
Hohhot, Inner Mongolia, China, 10000

Not yet recruiting

The Affiliated Hospital of Inner Mongolia Medical University
Contact:
Da Gao, Master
13947130473
Gaoda72@163.com
Jiangsu Locations
Nanjing, Jiangsu, China, 210000

Not yet recruiting

Jiangsu Provincial People's Hospital
Contact:
Lei Fan, Doctor
13813976136
fanlei3014@126.com
Jiangxi Locations
Nanchang, Jiangxi, China, 330006

Not yet recruiting

The First Affiliated Hospital of Nanchang University
Contact:
Fei Li, Doctor
13970038386
yx021021@sina.com
Liaoning Locations
Dalian, Liaoning, China, 116000

Not yet recruiting

The second Hospital of dalian
Contact:
Xiuhua Sun, Master
17709873631
3038668@vip.sina.com
Shaanxi Locations
Xi'an, Shaanxi, China, 710004

Not yet recruiting

The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
Contact:
Wanhong Zhao, Doctor
18991908852
13991365406@163.com
Shandong Locations
Jinan, Shandong, China, 250117

Recruiting

Affiliated Cancer Hospital of Shandong First Medical University
Contact:
Zengjun Li, Doctor
13642138692
zengjunli@163.com
Tai'an, Shandong, China, 271000

Not yet recruiting

Tai'an Central Hospital
Contact:
Ling Wang, Doctor
13583897631
13583897631@163.com
Shanghai Locations
Shanghai, Shanghai, China, 200063

Not yet recruiting

Tongji Hospital of Tongji University
Contact:
Ping Li, Doctor
13564181131
Lilyforever76@126.com
Shanxi Locations
TaiYuan, Shanxi, China, 030000

Not yet recruiting

Shanxi Cancer Hospital
Contact:
Liping Su, Doctor
13835158122
slpsy2022@163.com
Sichuan Locations
Luzhou, Sichuan, China, 646000

Not yet recruiting

The Affiliated Hospital of Southwest Medical University
Contact:
XiaoMing Li, Master
13700986866
Lxm6358@21cn.com
Zigong, Sichuan, China, 643000

Not yet recruiting

Zigong First People's Hospital
Contact:
Jian Xiao, Master
15881327002
16188702@qq.com
Tianjin Locations
Tianjin, Tianjin, China, 300122

Not yet recruiting

Tianjin People's Hospital
Contact:
Huaqing Wang, Doctor
18622221223
wanghuaqing@163.com
Tianjin, Tianjin, China, 300202

Not yet recruiting

Tianjin Medical University Cancer Institute and Hospital
Contact:
Shiyong Zhou, Doctor
13820041468
Zsy1003@163.com
Xinjiang Locations
Ürümqi, Xinjiang, China, 830000

Not yet recruiting

Affiliated Tumor Hospital of Xinjiang Medical University
Contact:
Shujuan Wen, Doctor
18160631686
736587502@qq.com
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
Show less
Ages Eligible for Study
18 Years to 75 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: TQB3702 tablets+Chemotherapy regimen

TQB3702 tablets 200mg, every 4 weeks for a treatment cycle.

Chemotherapy regimen:Every 3 or 4 weeks is a treatment cycle, with 6 or 12 cycles of combination therapy

Intervention/Treatment Drug: TQB3702 tablets+Chemotherapy regimen
  • TQB3702 tablets: Tyrosine kinase inhibitor;

    Chemotherapy regimen:inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis;

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Overall response rate (ORR)According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.Up to 2 years
Complete response rate (CRR)The rate of complete tumor remissionUp to 2 years
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Adverse events (AE) and serious adverse events (SAE)Incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicatorsBaseline to up to 28 days
ORR and CRR at the end of combination therapyObjective response rate and complete remission rate at the end of combination therapy.Up to 1 year
Progression-free survival (PFS)PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.Up to 2 years
Duration of response (DOR)The period from the participants first achieving CR or PR to disease progressionUp to 2 years
Overall survival (OS)OS is defined as the time from the first administration to all-cause deathUp to all-cause death
1-year PFS and OS1-year Progression-free survival and Overall survival ratesUp to 1 year
2-years PFS and OS2-years Progression-free survival and Overall survival ratesUp to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2024-08-21
First Submitted that Met QC Criteria
2024-08-21
First Posted
2024-08-22
Study Record Updates
Last Update Submitted that met QC Criteria
2024-11-18
Last Update Posted
2024-11-20
Last Verified
2024-04

More Information

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Additional Relevant MeSH Terms