A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
- Conditions
- B-cell Lymphoma
- Interventions
- Drug: TQB3702 tablets+Chemotherapy regimen
- Registration Number
- NCT06566586
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
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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;
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Histologically confirmed B-cell lymphomas of the following types that meet the 2022 World Health Organization (WHO) diagnostic criteria:
- Relapsed/refractory indolent B-cell lymphoma
- Diffuse large B cell lymphoma（DLBCL）
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Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at least one previous line of systemic standard therapy
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Have at least one measurable lesion.
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The main organs function well.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQB3702 tablets+Chemotherapy regimen 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
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) Up to 2 years 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.
Complete response rate (CRR) Up to 2 years The rate of complete tumor remission
- Secondary Outcome Measures
Name Time Method ORR and CRR at the end of combination therapy Up to 1 year Objective response rate and complete remission rate at the end of combination therapy.
Overall survival (OS) Up to all-cause death OS is defined as the time from the first administration to all-cause death
Adverse events (AE) and serious adverse events (SAE) Baseline to up to 28 days Incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators
Duration of response (DOR) Up to 2 years The period from the participants first achieving CR or PR to disease progression
1-year PFS and OS Up to 1 year 1-year Progression-free survival and Overall survival rates
2-years PFS and OS Up to 2 years 2-years Progression-free survival and Overall survival rates
Progression-free survival (PFS) Up to 2 years PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Trial Locations
- Locations (29)
Cancer Hospital Chinise Academy of Medical Sciences
🇨🇳BeiJing, Beijing, China
Gansu Provincial Cancer Hospital
🇨🇳Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Guigang City People's Hospital
🇨🇳Guigang, Guangxi, China
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
PuYang AnYang District Hospital
🇨🇳Anyang, Henan, China
Puyang People's Hospital
🇨🇳Puyang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
🇨🇳Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Xiangyang Central Hospital
🇨🇳XiangYang, Hubei, China
Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
🇨🇳Changsha, Hunan, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Jiangsu Provincial People's Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The second Hospital of dalian
🇨🇳Dalian, Liaoning, China
The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
🇨🇳Xi'an, Shaanxi, China
Affiliated Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Tai'an Central Hospital
🇨🇳Tai'an, Shandong, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer Hospital
🇨🇳TaiYuan, Shanxi, China
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Zigong First People's Hospital
🇨🇳Zigong, Sichuan, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Tumor Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China