A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

November 18, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • BeiJing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinise Academy of Medical Sciences
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Guigang, Guangxi, China, 537000
        • Not yet recruiting
        • Guigang City People's Hospital
        • Contact:
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Anyang, Henan, China, 450000
        • Not yet recruiting
        • Puyang Anyang District Hospital
        • Contact:
      • Puyang, Henan, China, 457000
        • Not yet recruiting
        • Puyang People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 457000
        • Not yet recruiting
        • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital Tongji Medical College Of Hust
        • Contact:
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
        • Contact:
      • XiangYang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangyang Central Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
        • Contact:
      • Zhuzhou, Hunan, China, 412000
        • Not yet recruiting
        • ZhuZhou Central Hospital
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 10000
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of NanChang University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Not yet recruiting
        • The second Hospital of dalian
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Affiliated Cancer Hospital of Shandong First Medical University
        • Contact:
      • Tai'an, Shandong, China, 271000
        • Not yet recruiting
        • Tai'an Central Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200063
        • Not yet recruiting
        • Tongji Hospital of Tongji University
        • Contact:
    • Shanxi
      • TaiYuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • Not yet recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
      • Zigong, Sichuan, China, 643000
        • Not yet recruiting
        • Zigong First People's Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300122
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300202
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Not yet recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: TQB3702 tablets+Chemotherapy regimen

TQB3702 tablets: Tyrosine kinase inhibitor；

Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis；

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 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.
Up to 2 years
Complete response rate (CRR)
Time Frame: Up to 2 years
The rate of complete tumor remission
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE) and serious adverse events (SAE)
Time Frame: 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
Baseline to up to 28 days
ORR and CRR at the end of combination therapy
Time Frame: Up to 1 year
Objective response rate and complete remission rate at the end of combination therapy.
Up to 1 year
Progression-free survival (PFS)
Time Frame: Up to 2 years
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Up to 2 years
Duration of response (DOR)
Time Frame: Up to 2 years
The period from the participants first achieving CR or PR to disease progression
Up to 2 years
Overall survival (OS)
Time Frame: Up to all-cause death
OS is defined as the time from the first administration to all-cause death
Up to all-cause death
1-year PFS and OS
Time Frame: Up to 1 year
1-year Progression-free survival and Overall survival rates
Up to 1 year
2-years PFS and OS
Time Frame: Up to 2 years
2-years Progression-free survival and Overall survival rates
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB3702-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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