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) .

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• Lymphoma 5,578
• Leukemia 5,441
• Leukemia, Lymphoid 1,780
• Leukemia, Lymphocytic, Chronic, B-Cell 1,603

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 107 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Study arms

• 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

Interventions

• DrugTQB3909 tablet

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

Primary outcomes

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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

8. 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).

   Time frame: Up to 34 months

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. Overall survival (OS)

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

   Time frame: Up to 34 months

7. 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

8. Maximum plasma drug concentration (Cmax)

   Cmax is the maximum plasma concentration of TQB3909.

   Time frame: Within 120 hours after administration

9. 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

10. 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

11. 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

12. 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