A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .

October 19, 2023 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.

This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

107

Phase

  • Phase 2
  • Phase 1

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
    • Anhui
      • Anqing, Anhui, China, 246004
        • Recruiting
        • Anqing Municipal Hospital
        • Contact:
    • Gansu
      • Wuwei, Gansu, China, 733000
        • Recruiting
        • Gansu province Wuwei tumour hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Canter
        • Contact:
    • Hebei
      • Chengde, Hebei, China, 067400
        • Recruiting
        • Affiliated Hospital of Chengde Medical College
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 150000
        • Recruiting
        • Harbin First Hospital
        • Contact:
          • Tiejun Gong, Master
          • Phone Number: 13836027737
          • Email: arc@sina.con
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410029
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Provincial People's Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • the First Affiliated Hospital of Soochow University
        • Contact:
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250063
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Linyi, Shandong, China, 276002
        • Recruiting
        • Linyi People's Hospital
        • Contact:
      • Tai'an, Shandong, China, 271000
        • Recruiting
        • Tai 'an Central Hospital
        • Contact:
          • Qingliang Teng, Master
          • Phone Number: 13375388422
          • Email: tatql@163.com
    • Shanghai
      • Shanghai, Shanghai, China, 200050
        • Recruiting
        • Shanghai Tongren Hospital
        • Contact:
          • Ligen Liu, Master
    • Shanxi
      • Changzhi, Shanxi, China, 460000
        • Recruiting
        • Peace Hospital Affiliated to Changzhi Medical College
        • Contact:
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • Recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
      • Mianyang, Sichuan, China, 621000
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
      • Yibin, Sichuan, China, 644000
        • Recruiting
        • Yibin Second People's Hospital
        • Contact:
          • Sihua Huang, Bachelor
          • Phone Number: 18284820022
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830054
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Contact:
          • Guifang Ouyang, Master
          • Phone Number: 13967810405
          • Email: nbougf@163.com

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 volunteered to join the study and signed informed consent form (ICF) with good compliance;
  • Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; The expected survival period is more than 3 months;
  • Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
  • Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showed measurable lesions;
  • Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7 days before study enrollment;

Exclusion Criteria:

  • Complicated diseases and medical history:

    1. It has appeared or is currently suffering from other malignant tumors within 3 years before the first medication. The following two situations can be included in the group: other malignant tumors treated by single surgery have achieved disease-free survival (DFS) for five consecutive years; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
    2. Lymphoma/leukemia is known to involve the central nervous system (CNS);
    3. Previously received allogeneic hematopoietic stem cell transplantation;
    4. Received autologous hematopoietic stem cell transplantation within 3 months before the first medication;
    5. Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
    6. Arterial/venous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
    7. Subjects with any serious and/or uncontrollable diseases;

  • Tumor-related symptoms and treatment:

    1. He has received chemotherapy and radiotherapy within 4 weeks before the first medication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and other small molecule anti-tumor treatments (the elution period is calculated from the end of the last treatment) before the first medication are within 5 half-lives;
    2. previously received BCL-2 inhibitors;
  • Research-related treatment: received the vaccine within 4 weeks before the first medication, or planned to be vaccinated during the study;
  • Participated in clinical trials of other antineoplastic drugs within 4 weeks before the first medication;
  • According to the investigators' judgment, there are patients with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who think that there are other reasons that are not suitable for inclusion.
  • Allergic to allopurinol and benzbromarone.

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: TQB3909 tablets
Oral administration, 400mg or 600 mg, once a day, and 28 days is a treatment cycle. Continue medication until the disease progresses or intolerant toxicity appears.
Drug: TQB3909 tablet
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AE)
Time Frame: Up to 34 months.
Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Severity of adverse events (AE)
Time Frame: Up to 34 months.
Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Incidence of serious adverse events (SAE)
Time Frame: Up to 34 months.
Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Severity of serious adverse events (SAE)
Time Frame: Up to 34 months.
Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Incidence of abnormal laboratory examination indexes.
Time Frame: Up to 34 months.
Incidence of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Severity of abnormal laboratory examination indexes.
Time Frame: Up to 34 months.
Severity of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Recommended phase II dose (RP2D)
Time Frame: Up to 18 months
To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL.
Up to 18 months
Objective remission rate (ORR) determined by Independent Review Committee (IRC)
Time Frame: Up to 34 months
Determine the objective remission rate (ORR) based on the evaluation results of the Independent Review Committee (IRC), defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
Up to 34 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR) determined by the investigators' evaluation.
Time Frame: Up to 34 months
The objective remission rate (ORR) was determined by the results of the investigator s' evaluation, defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
Up to 34 months
Duration of remission (DOR)
Time Frame: Up to 34 months
For all subjects whose best response was PR, CR,, the time from the date of first achieving PR, CR to the date of first definite disease progression or death from any cause (whichever occurs first).
Up to 34 months
Time to disease progression (TTP)
Time Frame: Up to 34 months
Refers to the time from the first medication to the objective progress of the disease.
Up to 34 months
Time to remission (TTR)
Time Frame: Up to 34 months
Time from the beginning of treatment to the first recording of remission (PR or better remission), only the remission population was analyzed.
Up to 34 months
Progression-free survival (PFS)
Time Frame: Up to 34 months
The time from the first medication to the objective progression of the disease or death caused from any cause (whichever comes first).
Up to 34 months
Overall survival (OS)
Time Frame: Up to 34 months
Time from first dose of study drug to date of death from any cause.
Up to 34 months
Time to reach maximum concentration (Tmax)
Time Frame: Within 120 hours after administration
Time to reach maximum plasma concentration after single and multiple dosing of TQB3909 tablets.
Within 120 hours after administration
Maximum plasma drug concentration (Cmax)
Time Frame: Within 120 hours after administration
Cmax is the maximum plasma concentration of TQB3909.
Within 120 hours after administration
Area under the plasma concentration-time curve (AUC0-t)
Time Frame: Within 120 hours after administration
To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve.
Within 120 hours after administration
Plasma elimination half-life (t1/2)
Time Frame: Within 120 hours after administration
t1/2 is time it takes for the blood concentration of TQB3909 to drop by half.
Within 120 hours after administration
Undetectable measurable residual disease (U-MRD) ratio of peripheral blood and/or bone marrow.
Time Frame: Up to 34 months
Refers to the undetected residual lesions. Peripheral blood and/or bone marrow are used to detect less than 1 CLL cell (less than 10-4) in 10000 white blood cells by flow cytometry.
Up to 34 months
Correlation between potential biomarkers and TQB3909 tablets.
Time Frame: Up to 34 months
Correlation of potential biomarkers with TQB3909 tablets: such as BTK and PLCG2 mutation status and allele frequency.
Up to 34 months

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)

October 11, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB3909-Ib/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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