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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3909 tablets | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3909 tablet | Drug | TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | 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) | 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) | 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) | 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. | 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. | 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) | To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate (ORR) determined by the investigators' evaluation. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Complicated diseases and medical history:
Tumor-related symptoms and treatment:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianyong Li, Doctor | Contact | +86 13951877733 | Ljianyonglm@mcdmail.com | |
| Keshu Zhou, Doctor | Contact | +86 13674902391 | drzhouks77@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing Municipal Hospital | Recruiting | Anqing | Anhui | 246004 | China |
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| Up to 18 months |
| Objective remission rate (ORR) determined by Independent Review Committee (IRC) | 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 |
| Duration of remission (DOR) |
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) | Refers to the time from the first medication to the objective progress of the disease. | Up to 34 months |
| Time to remission (TTR) | 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) | 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 from first dose of study drug to date of death from any cause. | Up to 34 months |
| Time to reach maximum concentration (Tmax) | Time to reach maximum plasma concentration after single and multiple dosing of TQB3909 tablets. | Within 120 hours after administration |
| Maximum plasma drug concentration (Cmax) | Cmax is the maximum plasma concentration of TQB3909. | Within 120 hours after administration |
| Area under the plasma concentration-time curve (AUC0-t) | 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) | 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. | 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. | Correlation of potential biomarkers with TQB3909 tablets: such as BTK and PLCG2 mutation status and allele frequency. | Up to 34 months |
| Gansu province Wuwei tumour hospital | Recruiting | Wuwei | Gansu | 733000 | China |
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| Sun Yat-Sen University Cancer Canter | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Affiliated Hospital of Chengde Medical College | Recruiting | Chengde | Hebei | 067400 | China |
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| Harbin first hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150000 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410029 | China |
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| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215004 | China |
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| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| Shengjing Hospital Affiliated to China Medical University | Recruiting | Shenyang | Liaoning | 110000 | China |
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| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250063 | China |
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| Linyi people's hospital | Recruiting | Linyi | Shandong | 276002 | China |
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| Tai 'an Central Hospital | Recruiting | Tai’an | Shandong | 271000 | China |
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| Shanghai Tongren Hospital | Recruiting | Shanghai | Shanghai Municipality | 200050 | China |
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| Peace Hospital Affiliated to Changzhi Medical College | Recruiting | Changzhi | Shanxi | 460000 | China |
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| Affiliated hospital of southwest medical university | Recruiting | Luzhou | Sichuan | 646000 | China |
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| Mianyang Central Hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
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| Yibin Second People's Hospital | Recruiting | Yibin | Sichuan | 644000 | China |
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| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang Uygur Autonomous Region | 830054 | China |
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| The First Affiliated Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315010 | China |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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