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
- Registration Number
- NCT06566586
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria:<br><br> - The subjects voluntarily joined the study, signed the informed consent, and the<br> compliance was good;<br><br> - Age: 18 years old = age (when signing the informed consent) =75 years old; Eastern<br> cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3<br> months;<br><br> - Histologically confirmed B-cell lymphomas of the following types that meet the 2022<br> World Health Organization (WHO) diagnostic criteria:<br><br> 1. Relapsed/refractory indolent B-cell lymphoma<br><br> 2. Diffuse large B cell lymphoma(DLBCL)<br><br> - Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at<br> least one previous line of systemic standard therapy<br><br> - Have at least one measurable lesion.<br><br> - The main organs function well.<br><br> - Female subjects of reproductive age should agree to use contraception (such as Iuds,<br> contraceptives, or condoms) during the study period and for 6 months after the end<br> of the study; Have a negative serum pregnancy test within 7 days prior to study<br> enrollment and must be a non-lactating subject; Male subjects should agree to use<br> avoidance during the study period and for 6 months after the end of the study<br> period.<br><br>Exclusion Criteria:<br><br> - Have had or are currently suffering from other malignant tumors within 3 years prior<br> to the first medication.<br><br> - Known or suspected central nervous system (CNS) aggression.<br><br> - Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem<br> cell transplantation, or autologous hematopoietic stem cell transplantation within 3<br> months before the first treatment;<br><br> - Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to<br> = National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1<br> due to any previous treatment, excluding hair loss and fatigue;<br><br> - Have multiple factors that affect oral drug absorption (such as inability to<br> swallow, chronic diarrhea, and intestinal obstruction);<br><br> - Received major surgical treatment or significant traumatic injury within 28 days<br> before the start of study treatment;<br><br> - Hyperkinetic/venous thrombosis events occurred within 6 months before the first<br> medication;<br><br> - Have a history of psychotropic drug abuse and can not quit or have mental disorders;<br><br> - Subjects with any severe and/or uncontrolled disease;<br><br> - Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks<br> before the first dose, or planned to receive live vaccine or mRNA vaccine during the<br> study;<br><br> - Participated in clinical trials of other antitumor drugs within 4 weeks before the<br> first medication;<br><br> - Subjects who, in the judgment of the investigator, have concomitant diseases that<br> seriously endanger the safety of the subjects or affect the completion of the study,<br> or subjects who are not suitable for enrollment for other reasons.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR);Complete response rate (CRR)
- Secondary Outcome Measures
Name Time Method Adverse events (AE) and serious adverse events (SAE);ORR and CRR at the end of combination therapy;Progression-free survival (PFS);Duration of response (DOR);Overall survival (OS);1-year PFS and OS;2-years PFS and OS