Small Lymphocytic LympphoPhase 3NCT07753369

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)

A Phase 3 study testing TQB3909 Tablets, Bendamustine Injection and Rituximab injection in people with Small Lymphocytic Lymppho and Relapsed/Refractory Chronic Lymphocytic Leukemia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Small Lymphocytic Lymppho, Relapsed/Refractory Chronic Lymphocytic Leukemia
What is being tested?: TQB3909 Tablets, Bendamustine Injection and Rituximab injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 2 sitesChina
Study dates: Aug 2026to Dec 2030
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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;

Show all 23Show fewer

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:
Chemotherapy, monoclonal antibody therapy, or radiotherapy within 4 weeks prior to the first dose; immune checkpoint inhibitors or CAR-T therapy within 12 weeks prior to the first dose; other small-molecule anti-tumor therapies within 5 half-lives (calculated from the end date of the last treatment);
Corticosteroids administered for anti-tumor purposes; short-term (≤7 days) systemic corticosteroid therapy (≤20 mg prednisone equivalent) to control lymphoma-related symptoms or BTKi withdrawal symptoms prior to enrollment is permitted, but tapering to discontinuation within 5 days after study start is required;
Prior treatment with BCL-2 inhibitors;
Retreatment with bendamustine is allowed if the prior response to bendamustine lasted >24 months;
Study Treatment-Related: Vaccination within 4 weeks prior to the first dose, or planned vaccination during the study;
Participation in other anti-tumor drug clinical trials within 4 weeks prior to the first dose; for small-molecule targeted drugs with defined targets such as BTK inhibitors, calculated as 5 half-lives;
Subjects with concomitant diseases that seriously endanger subject safety or affect study completion, or subjects considered unsuitable for enrollment for other reasons, as judged by the investigator;
Allergy to both allopurinol and benzbromarone.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Yong Li, doctor contact

13951877733

lijianyonglm@126.com

Ke Shu Zhou, doctor contact

13674902391

dr_zkshu23810@163.com

China2 sites

Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Jian Yong Li, doctor, 13951877733, lijianyonglm@126.com
Henan Province
Zhengzhou, Henan
KeShu Zhou, doctor, 13674902391, dr_zkshu23810@163.com

Other trials in China

About this study

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)

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
Being tested: TQB3909 Tablets, Bendamustine Injection, Rituximab injection, Lenalidomide Capsules
Medical subject headings: Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TQB3909 TabletsDrug
TQB3909 Tablets is a BCL-2 inhibitor.
Bendamustine InjectionDrug
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 injectionDrug
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 CapsulesDrug
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.

Study groups in NCT07753369
Study group	Role	What they receive
TQB3909 Tablets	Experimental	The drug was administered every day for 28 consecutive days in a treatment cycle Receives: 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. Receives: Drug: Bendamustine Injection; Drug: Rituximab injection; Drug: Lenalidomide Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression free survival (PFS) evaluated by an independent review committee (IRC)
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Measured: Up to 4 years

Secondary outcomes (4)

Overall Survival (OS)
the time interval from the start of first study treatment to death due to any cause.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2026Dec 2030

First posted7 Aug 2026
Study startAug 2026 (estimated)
Primary completionDec 2030 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Small Lymphocytic LympphoStudies of the same condition, open and under way.
More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07753369
Sponsor's protocol ID: TQB3909-III-01
Status last verified: Aug 2026
First submitted: 4 Aug 2026
Last updated: 11 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No