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NOT YET RECRUITING
NCT07753369
PHASE3

A Clinical Trial 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)

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

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)

Official title: A Randomized, Open-Label, Multicenter, Phase III Clinical Trial 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2026-08

Completion Date

2030-12

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

TQB3909 Tablets

TQB3909 Tablets is a BCL-2 inhibitor.

DRUG

Bendamustine Injection

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.

DRUG

Rituximab injection

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.

DRUG

Lenalidomide Capsules

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.

Locations (2)

Henan Province

Zhengzhou, Henan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China