Actively Recruiting
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2024-11-20
80
Participants Needed
30
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for treating B-cell lymphoma. This Phase II clinical trial focuses on patients diagnosed with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B-cell lymphoma (DLBCL). The study aims to assess how well this combination therapy works and its overall safety. Participants will receive TQB3702 tablets at a dose of 200 mg every 4 weeks as one treatment cycle. Alongside this, they will undergo chemotherapy cycles every 3 or 4 weeks, with a total of 6 to 12 cycles of combination therapy. The chemotherapy regimen is designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, support immune function, and prevent new blood vessel formation that supports tumors. During the trial, participants will be closely monitored for treatment response and safety. Researchers will measure overall and complete response rates up to 2 years, as well as adverse events, progression-free survival, duration of response, and overall survival up to death from any cause. The study includes assessments from baseline through combination therapy completion and follow-up periods lasting up to 2 years. This comprehensive monitoring helps understand both the immediate and longer-term effects of the treatment.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily agree to join and sign informed consent with good compliance
- Age between 18 and 75 years at consent signing
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Expected survival longer than 3 months
- Histologically confirmed B-cell lymphoma meeting 2022 WHO criteria, including relapsed/refractory indolent B-cell lymphoma or diffuse large B-cell lymphoma (DLBCL)
- For relapsed/refractory indolent B-cell lymphoma, must have received at least one prior standard systemic therapy
- At least one measurable lesion
- Good function of main organs
- Female participants of reproductive age must agree to use contraception during the study and for 6 months after, have a negative pregnancy test within 7 days before enrollment, and not be breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- History or current presence of other malignant tumors within 3 years before starting medication
- Known or suspected central nervous system (CNS) involvement
- For relapsed/refractory indolent B-cell lymphoma, previous allogeneic hematopoietic stem cell transplant or autologous transplant within 3 months before treatment
- Toxic reactions from previous treatments not resolved to less than or equal to Grade 1 (excluding hair loss and fatigue) per NCI-CTC criteria
- Conditions affecting oral drug absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Major surgery or serious injury within 28 days before starting study treatment
- Hyperkinetic or venous thrombosis events within 6 months before treatment
- History of psychotropic drug abuse or ongoing mental disorders
- Severe or uncontrolled diseases
- Receipt of live or mRNA vaccines within 4 weeks before first dose or planned vaccination during the study
- Participation in other antitumor drug clinical trials within 4 weeks before first dose
- Any other diseases or conditions that may endanger safety or affect study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 cycles of combination therapy, with each chemotherapy cycle every 3 or 4 weeks
Participants receive TQB3702 tablets combined with chemotherapy to treat B-cell lymphoma.
Visits every 3 or 4 weeks for up to 12 cycles
Duration - Up to 2 years
Participants are monitored for safety and treatment efficacy after completion of combination therapy.
Periodic visits during follow-up period
Trial Site Locations
Total: 30 locations
1
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
Guigang City People's Hospital
Guigang, Guangxi, China, 537000
Not Yet Recruiting
5
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
7
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
8
PuYang AnYang District Hospital
Anyang, Henan, China, 450000
Not Yet Recruiting
9
Puyang People's Hospital
Puyang, Henan, China, 457000
Not Yet Recruiting
10
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
11
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China, 457000
Not Yet Recruiting
12
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan, Hubei, China, 430022
Not Yet Recruiting
13
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
Not Yet Recruiting
14
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
Not Yet Recruiting
15
Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China, 410013
Not Yet Recruiting
16
Zhuzhou Central Hospital
Zhuzhou, Hunan, China, 412000
Not Yet Recruiting
17
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 10000
Not Yet Recruiting
18
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
19
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
20
The second Hospital of dalian
Dalian, Liaoning, China, 116000
Not Yet Recruiting
21
The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
22
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Actively Recruiting
23
Tai'an Central Hospital
Tai’an, Shandong, China, 271000
Not Yet Recruiting
24
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200063
Not Yet Recruiting
25
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
26
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
27
Zigong First People's Hospital
Zigong, Sichuan, China, 643000
Not Yet Recruiting
28
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300122
Not Yet Recruiting
29
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300202
Not Yet Recruiting
30
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
Research Team
Z
Zengjun Li, Doctor
F
Fei Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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