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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.
Incidence of adverse events (AE)
Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Up to 18 months
Objective remission rate (ORR) determined by Independent Review Committee (IRC)
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Anqing Municipal Hospital
Anqing, Anhui, China
RECRUITINGGansu province Wuwei tumour hospital
Wuwei, Gansu, China
RECRUITINGSun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, China
RECRUITINGAffiliated Hospital of Chengde Medical College
Chengde, Hebei, China
RECRUITINGHarbin first hospital
Harbin, Heilongjiang, China
RECRUITINGThe Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGJiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITING...and 15 more locations
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).
Time frame: Up to 34 months
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).
Time frame: 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).
Time frame: Up to 34 months
Time to disease progression (TTP)
Refers to the time from the first medication to the objective progress of the disease.
Time frame: 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.
Time frame: 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).
Time frame: Up to 34 months
Overall survival (OS)
Time from first dose of study drug to date of death from any cause.
Time frame: Up to 34 months
Time to reach maximum concentration (Tmax)
Time to reach maximum plasma concentration after single and multiple dosing of TQB3909 tablets.
Time frame: Within 120 hours after administration
Maximum plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3909.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 34 months