A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
1 other identifier
interventional
80
1 country
30
Brief Summary
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2024
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Start
First participant enrolled
November 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedNovember 20, 2024
April 1, 2024
1.3 years
August 21, 2024
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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 remission
Up to 2 years
Secondary Outcomes (7)
Adverse events (AE) and serious adverse events (SAE)
Baseline to up to 28 days
ORR and CRR at the end of combination therapy
Up to 1 year
Progression-free survival (PFS)
Up to 2 years
Duration of response (DOR)
Up to 2 years
Overall survival (OS)
Up to all-cause death
- +2 more secondary outcomes
Study Arms (1)
TQB3702 tablets+Chemotherapy regimen
EXPERIMENTALTQB3702 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
Interventions
TQB3702 tablets: Tyrosine kinase inhibitor； Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis；
Eligibility Criteria
You may qualify if:
- 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:
- Relapsed/refractory indolent B-cell lymphoma
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
Guigang City People's Hospital
Guigang, Guangxi, 537000, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
PuYang AnYang District Hospital
Anyang, Henan, 450000, China
Puyang People's Hospital
Puyang, Henan, 457000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 457000, China
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410013, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10000, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The second Hospital of dalian
Dalian, Liaoning, 116000, China
The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
Xi'an, Shaanxi, 710004, China
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
Tai'an Central Hospital
Tai’an, Shandong, 271000, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200063, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Zigong First People's Hospital
Zigong, Sichuan, 643000, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300122, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300202, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2024
First Posted
August 22, 2024
Study Start
November 6, 2024
Primary Completion
March 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
November 20, 2024
Record last verified: 2024-04