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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
TQB3909 Tablets is a BCL-2 inhibitor.
Bendamustine 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 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 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.
Henan Province
Zhengzhou, Henan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Time frame: Up to 4 years
Overall Survival (OS)
the time interval from the start of first study treatment to death due to any cause.
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
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
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
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