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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)

NCT07753369 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-08-11

No results posted yet for this study

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)

Conditions

  • Small Lymphocytic Lymppho
  • Relapsed/Refractory Chronic Lymphocytic Leukemia

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753369 on ClinicalTrials.gov