Clinical trial NCT06566586: A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: B-cell Lymphoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma


Eligibility 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to 2 years
measure: Complete response rate (CRR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Adverse events (AE) and serious adverse events (SAE)
timeFrame: Baseline to up to 28 days
measure: ORR and CRR at the end of combination therapy
timeFrame: Up to 1 year
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years
measure: Duration of response (DOR)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to all-cause death
measure: 1-year PFS and OS
timeFrame: Up to 1 year
measure: 2-years PFS and OS
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Cancer Hospital Chinise Academy of Medical Sciences
state: Beijing
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guigang
country: China
facility: Guigang City People's Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Anyang
country: China
facility: PuYang AnYang District Hospital
state: Henan
city: Puyang
country: China
facility: Puyang People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST
state: Hubei
city: XiangYang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
state: Hunan
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: The second Hospital of dalian
state: Liaoning
city: Xi'an
country: China
facility: The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
state: Shaanxi
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
city: Tai'an
country: China
facility: Tai'an Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: TaiYuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Zigong
country: China
facility: Zigong First People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Ürümqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
References: