To Evaluate the Efficacy and Safety of TQB3909 Tablets versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
The subject voluntarily agrees to participate in this study, signs the informed consent form, and is expected to be compliant.
Age: ≥18 years; ECOG PS score: 0-2; expected survival >3 months.
Patients with a confirmed diagnosis of CLL/SLL according to the diagnostic criteria of the revised 2018 iwCLL guidelines;
Meet at least one indication for treatment of CLL/SLL according to the revised 2018 iwCLL guidelines;
History of or concurrent other malignancies within 3 years prior to the first dose. The following two conditions are allowed: other malignancies treated with surgery alone and achieving continuous disease-free survival (DFS) of 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading lamina propria)];
History of Richter's transformation or prolymphocytic leukemia (PLL);
Known lymphoma/leukemia involvement of the central nervous system (CNS);
Prior allogeneic hematopoietic stem cell transplantation;
Parallel
TQB3909 Tablets
DrugTQB3909 Tablets is a BCL-2 inhibitor.
Bendamustine Injection
DrugBendamustine A bifunctional alkylating agent with dual characteristics of both an alkylating agent and a purine analogue. It exerts its anti-tumor effects by forming DNA cross-links and inducing single-strand and double-strand DNA breaks, thereby blocking DNA replication and transcription in tumor cells and ultimately leading to apoptosis. It is not fully cross-resistant with other alkylating agents.
Rituximab injection
DrugRituximab A chimeric anti-CD20 monoclonal antibody. It targets the CD20 antigen on the surface of B lymphocytes and kills cells through three mechanisms: antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. It primarily depletes B cells (including both normal and malignant B cells) and is effective against B-cell-derived lymphomas/leukemias such as CLL/SLL.
Lenalidomide Capsules
DrugLenalidomide An immunomodulatory drug (IMiD) that binds to the E3 ubiquitin ligase substrate recognition protein cereblon, promoting the ubiquitination and degradation of transcription factors Ikaros and Aiolos. Its downstream effects include: enhancing the anti-tumor activity of NK cells and T cells, directly inducing tumor cell apoptosis, inhibiting tumor angiogenesis, and modulating the tumor microenvironment.
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Overall Survival (OS)
the time interval from the start of first study treatment to death due to any cause.
Progression free survival (PFS) evaluated by researchers
The time from randomization to researcher evaluation of disease progression or death from any cause (whichever occurs first) is determined according to the 2014 Lugano criteria and LYRIC.
Objective response rate (ORR)
The percentage of complete (CR) or partial response (PR) subjects determined by IRC based on the 2014 Lugano criteria or by researchers based on the 2014 Lugano criteria and LYRIC, respectively
Duration of Response (DOR) per Independent Review Committee (IRC) and investigator assessment
defined as the time from the date of first documented Complete Response (CR) or Partial Response (PR) to the date of first documented disease progression, start of new anti-tumor therapy, or death.
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