Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

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.

TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.

TQB3909 tablet

Jianyong Li, Doctor

Keshu Zhou, Doctor

Fusheng Yao, Doctor

Cong Wang, Bachelor

Zhiming Li, Doctor

Zhihua Zhang, Master

Tiejun Gong, Master

Wang Wei, Doctor

Yajun Li, Doctor

Bingzong Li, Doctor

Zhengming Jin, Bachelor

Feng Zhu, Doctor

Wuping Li, Doctor

Wei Yang, Doctor

Jie Li, Doctor

Haiyan Zhang, Master

Qingliang Teng, Master

Ligen Liu, Master

Xuliang Shen, Doctor

Xiaoming Li, Master

Xiaobo Du, Doctor

Sihua Huang, Bachelor

Yafei Wang, Doctor

Jianhua Qu, Master

Guifang Ouyang, Master

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.

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) .

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

Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).

Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).

Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).

Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).

Incidence of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).

Severity of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).

To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL.

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).

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).

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).

Refers to the time from the first medication to the objective progress of the disease.

Time from the beginning of treatment to the first recording of remission (PR or better remission), only the remission population was analyzed.

The time from the first medication to the objective progression of the disease or death caused from any cause (whichever comes first).

Time from first dose of study drug to date of death from any cause.

Time to reach maximum plasma concentration after single and multiple dosing of TQB3909 tablets.

Cmax is the maximum plasma concentration of TQB3909.

To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve.

t1/2 is time it takes for the blood concentration of TQB3909 to drop by half.

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.

Correlation of potential biomarkers with TQB3909 tablets: such as BTK and PLCG2 mutation status and allele frequency.

Spots Global Cancer Trial Database for tqb3909 tablet