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 | Not Yet Recruiting Phase 3

• 1 other identifier: TQB3909-III-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) evaluated by an independent review committee (IRC)

  Progression free survival (PFS) evaluated by an independent review committee (IRC)

  Up to 4 years

Secondary Outcomes (4)

• Overall Survival (OS)

  Up to 4 years

• Progression free survival (PFS) evaluated by researchers

  Up to 4 years

• Objective response rate (ORR)

  Up to 4 years

• Duration of Response (DOR) per Independent Review Committee (IRC) and investigator assessment

  Up to 4 years

Study Arms (2)

TQB3909 Tablets

EXPERIMENTAL

The drug was administered every day for 28 consecutive days in a treatment cycle

Drug: TQB3909 Tablets

BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection

ACTIVE COMPARATOR

BR Regimen Bendamustine Hydrochloride for Injection: 70 mg/m², intravenous (IV) administration on Days 1-2 of each cycle. IV infusion over 60-120 minutes. Rituximab Injection: Intravenous administration at 375 mg/m² on Day 1 of Cycle 1, and at 500 mg/m² on Day 1 of Cycles 2-6. R2 Regimen Lenalidomide Capsules: 10 mg/day, orally starting from Day 9 of Cycle 1. Each cycle consists of 28 days. Rituximab Injection: 375 mg/m², intravenous (IV) administration on Days 1, 8, 15, and 22 of Cycle 1, followed by 375 mg/m² on Day 1 of Cycles 3-12. Each cycle consists of 28 days.

Drug: Bendamustine Injection; Drug: Rituximab injection; Drug: Lenalidomide Capsules

Interventions

TQB3909 Tablets DRUG

TQB3909 Tablets is a BCL-2 inhibitor.

TQB3909 Tablets

Bendamustine Injection DRUG

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.

BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection

Rituximab injection DRUG

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.

BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection

Lenalidomide Capsules DRUG

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.

BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject population:
• 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;
• Have developed treatment intolerance during or after immunochemotherapy and BTK inhibitor therapy, or have failed to achieve PR or better response after adequate treatment, or have experienced disease progression. For patients assessed by the investigator as unfit for immunochemotherapy, they must have developed treatment intolerance during BTK inhibitor therapy, failed to achieve PR or better response after adequate treatment, or experienced disease progression after adequate treatment.
• Adequate major organ function.
• SLL patients must have measurable disease on CT/MRI.
• Female subjects of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the last dose; serum pregnancy test must be negative within 7 days prior to enrollment, and must not be breastfeeding. Male subjects must agree to use contraception during the study and for 6 months after the last dose.

You may not qualify if:

• Comorbidities and Medical History:
• 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;
• Autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;
• Multiple factors affecting oral drug administration (e.g., inability to swallow, chronic diarrhea, bowel obstruction, etc.);
• Active or uncontrolled autoimmune cytopenia despite low-dose glucocorticoid therapy (equivalent to prednisone 20 mg), including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP);
• Toxicity from any prior treatment that has not recovered to ≤ Grade 1 per CTCAE, excluding alopecia, neutrophil count, and platelet count;
• Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment;
• Severe arterial/venous thromboembolic events within 3 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, intracranial hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.;
• History of psychoactive substance abuse that cannot be discontinued, or psychiatric disorders;
• Subjects with any severe and/or uncontrolled diseases, including:
• Myocardial ischemia or myocardial infarction ≥ Grade 2, arrhythmia (QTcF \>450 ms for males, QTcF \>470 ms for females), and ≥ Grade 2 congestive heart failure (New York Heart Association \[NYHA\] classification), or left ventricular ejection fraction (LVEF) \<50% by echocardiography within 6 months prior to the first dose; Active infection (≥ Grade 2 infection per CTCAE); Active hepatitis\*; Hepatitis B: HBV DNA ≥ lower limit of detection; Hepatitis C: HCV antibody positive and HCV viral titer \> lower limit of detection; History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; Epilepsy requiring treatment;
• Tumor-Related Symptoms and Treatment:

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Henan Province

Zhengzhou, Henan, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles

Central Study Contacts

Jian Yong Li, doctor

CONTACT

13951877733; lijianyonglm@126.com

Ke Shu Zhou, doctor

CONTACT

13674902391; dr_zkshu23810@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

CN (2)