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.
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
- Are there results?
- Not yet: the study is under way
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.
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- 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;
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- 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.
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
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)
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07753369
- Acronym / sponsor ID
- TQB3909-III-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB3909 Tablets | Experimental | Drug: TQB3909 TabletsThe drug was administered every day for 28 consecutive days in a treatment cycle |
| BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection | Active comparator | Drug: Bendamustine Injection, Drug: Rituximab injection, Drug: Lenalidomide CapsulesBR 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Adequate major organ function.
- SLL patients must have measurable disease on CT/MRI.
Key exclusion criteria (23 listed)
- Comorbidities and Medical History:
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3909 TabletsTQB3909 Tablets is a BCL-2 inhibitor. | Drug | TQB3909 Tablets |
| Bendamustine InjectionBendamustine 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 | BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection |
| Rituximab injectionRituximab 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 | BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection |
| Lenalidomide CapsulesLenalidomide 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. | Drug | BR Regimen Bendamustine injection+ Rituximab or R2 Lenalidomide Capsules + Rituximab injection |
Primary outcome
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Time frame: Up to 4 years
Progression free survival (PFS) evaluated by an independent review committee (IRC)
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 4 years
Progression free survival (PFS) evaluated by researchers
Time frame: Up to 4 years
Objective response rate (ORR)
Time frame: Up to 4 years
Duration of Response (DOR) per Independent Review Committee (IRC) and investigator assessment
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Yong Li, doctor (13951877733, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) evaluated by an independent review committee (IRC) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.