Evaluating TQB3702 tablets with immunochemotherapy for B-cell lymphoma treatment
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
This study is testing if TQB3702 tablets can work better with immunochemotherapy to help people with relapsed or hard-to-treat B-cell lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Locations | 30 sites (Beijing, Beijing Municipality and 29 other locations) |
| Trial ID | NCT06566586 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the efficacy and safety of TQB3702 tablets when combined with immunochemotherapy in patients diagnosed with B-cell lymphoma. Participants will receive the TQB3702 treatment alongside a standard chemotherapy regimen. The study will focus on patients with relapsed or refractory forms of B-cell lymphoma, ensuring that they meet specific eligibility criteria, including age and health status. The goal is to determine whether this combination therapy can improve treatment outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed relapsed or refractory B-cell lymphoma who have previously undergone systemic therapy.
Not a fit: Patients with non-B-cell lymphoma or those who do not meet the specified health and treatment criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from B-cell lymphoma.
How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy for lymphoma treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 29 other locations
- Cancer Hospital Chinise Academy of Medical Sciences — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Guigang City People's Hospital — Guigang, Guangxi, China (Not_yet_recruiting)
- Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
- Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
- PuYang AnYang District Hospital — Anyang, Henan, China (Not_yet_recruiting)
- Puyang People's Hospital — Puyang, Henan, China (Not_yet_recruiting)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
- Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy — Wuhan, Hubei, China (Not_yet_recruiting)
- Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China (Not_yet_recruiting)
- Xiangyang Central Hospital — Xiangyang, Hubei, China (Not_yet_recruiting)
- Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China (Not_yet_recruiting)
- Zhuzhou Central Hospital — Zhuzhou, Hunan, China (Not_yet_recruiting)
- The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
- Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
- The second Hospital of dalian — Dalian, Liaoning, China (Not_yet_recruiting)
- The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital) — Xi'an, Shaanxi, China (Not_yet_recruiting)
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)
- Tai'an Central Hospital — Tai’an, Shandong, China (Not_yet_recruiting)
- Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
- The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
- Zigong First People's Hospital — Zigong, Sichuan, China (Not_yet_recruiting)
- Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
- Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
- Affiliated Tumor Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Zengjun Li, Doctor
- Email: zengjunli@163.com
- Phone: 13642138692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.