Diffuse Large B Cell LymphomaPhase 2NCT05940064
Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell Lymphoma
A Phase 2 study testing Zanubrutinib, Polatuzumab Vedotin, Rituximab in people with Diffuse Large B Cell Lymphoma, run by Peng Liu at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Zanubrutinib, Polatuzumab Vedotin, Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be enrolled in this study:
- Patients with histopathologically confirmed DLBCL;
- Patients haven't received any anti-DLBCL therapy. Corticosteroids alone is not considered as a line of treatment;
- The age of patients ≥ 70 years old, or between 60 and 69 but with an ECOG score between 2-4;
- Patients intolerant to standard front-line therapy, i.e. R-CHOP, or R-miniCHOP etc.
- Good organ function;
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- Measurable lesions detected by radiological imaging were defined as the longest diameter of at least 1 lymph node lesion > 1.5 cm, or the longest diameter of at least 1 extranodal lesion > 1.0 cm, and at least 2 vertical diameters that could be accurately measured;
- Life expectancy ≥ 6 months;
- Sign written informed consent.
Who cannot join
- Patients with any of the following conditions cannot be enrolled in this study:
- Patients with primary central nervous system lymphoma;
- Patients with previous exposure to BTK inhibitors;
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc; Currently clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or history of myocardial infarction within 6 months after screening. The left ventricular ejection fraction measured by echocardiography was < 50%;
- Abnormal laboratory indicators at screening (unless caused by lymphoma):
- 4.1 ANC<1.5×10^9/l, PLT<80×10^9/l 4.2 Coagulation function: INR greater than 1.5 times the upper limit of normal value; Pt and APTT were greater than 1.5 times the upper limit of normal 4.3 Liver function: ALT or ast was 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal 4.4 Renal function: creatinine was 1.5 times higher than the upper limit of normal, creatinine clearance rate was < 60 ml/min (estimated according to Cockcroft Gault formula)
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- HIV-infected persons;
- HCV active infection;
- HBsAg positive patients need to be HBV DNA negative before enrollment; In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA testing is still required. If the result is positive, antiviral treatment is required, and HBV DNA is required to be negative before enrollment;
- Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study, including psychiatric patients or other patients who are known or suspected to be unable to fully comply with the study protocol;
- Known allergy to test drug;
- Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction;
- Pregnant or lactating women;
- Corticosteroids (dose equivalent to prednisone > 20 mg/ day) were previously given for antitumor purposes within 7 days, and chemotherapy, targeted therapy, or radiotherapy were previously received within 3 weeks, or antibody-based therapy was received within 3 weeks, or traditional Chinese medicine anticancer therapy was performed within 4 weeks;
- Major surgery was performed within 4 weeks after screening;
- Sustained treatment with potent and moderate CYP3A inhibitors or CYP3A inducers is needed. Patients could not be enrolled if they had taken potent and moderate CYP3A inhibitors or CYP3A inducers within 7 days before the first administration of study drugs (or had taken these drugs for no more than 5 half-lives).
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Prospective Single-arm, Single-center Clinical Study of Zanubrutinib, Polatuzumab Vedotin and Rituximab (ZPR) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma
This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma.
Read the detailed description
This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma.
Primary objective: use ORR to evaluate the efficacy of ZPR in treating elderly treatment-naive DLBCL patients
Secondary objective: Evaluate the safety of ZPR treatment for elderly treatment-naive DLBCL patients
The subjects received 6 cycles of ZPR regimen, one cycle every 21 days. Then Zanubrutinib alone will continue to be used until Zanubrutinib has been used for 1 year or disease progression or intolerable adverse effects, death, withdrawal of informed consent or study termination.
Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m^2 ivgtt D1.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Zanubrutinib, Polatuzumab Vedotin, Rituximab
- Keywords
- Diffuse Large B Cell Lymphoma, Treatment-naive, Elderly, Zanubrutinib, Polatuzumab Vedotin, Rituximab, Efficacy, Safety
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib, Polatuzumab Vedotin, RituximabDrug
Also called ZPR
Drug: Zanubrutinib, Polatuzumab Vedotin and Rituximab Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab Vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m^2 ivgtt D1
| Study group | Role | What they receive |
|---|---|---|
| Elderly Treatment-naive Diffuse Large B-cell Lymphoma | Experimental | Elderly Treatment-naive Diffuse Large B-cell Lymphoma Receives: Drug: Zanubrutinib, Polatuzumab Vedotin, Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR at the end of the 6th treatment cycle
the proportion of participants who have achieved complete or partial remission determined by the researcher.
Measured: about six months from the start of ZPR
Secondary outcomes (3)
CRR at the end of the 6th treatment cycle
the proportion of subjects evaluated by researchers to obtain CR.
Measured: about six months from the start of ZPR
Proportion of patients who have achieved 2-year PFS
Defined as the proportion of participants with a time of 2 years from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence
Measured: 2-year (from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence)
Safety evaluation
incidence and severity of adverse events (AE) and Serious adverse event (SAE) during the study
Measured: between the first administration of the study drug and 30 days after discontinuation, or during the progression of the disease or the initiation of new anticancer treatment, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start20 Dec 2023
- Primary completion15 Jan 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940064
- Sponsor's protocol ID
- SHZS-DLBCL003
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-arm, Single-center Clinical Study of Zanubrutinib, Polatuzumab Vedotin and Rituximab (ZPR) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05940064
- Acronym / sponsor ID
- SHZS-DLBCL003
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse Large B Cell Lymphoma, Treatment-naive, Elderly, Zanubrutinib, Polatuzumab Vedotin, Rituximab, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peng LiuUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 11 Jul 2023 (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.
This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma.
Detailed description
This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma.
Primary objective: use ORR to evaluate the efficacy of ZPR in treating elderly treatment-naive DLBCL patients
Secondary objective: Evaluate the safety of ZPR treatment for elderly treatment-naive DLBCL patients
The subjects received 6 cycles of ZPR regimen, one cycle every 21 days. Then Zanubrutinib alone will continue to be used until Zanubrutinib has been used for 1 year or disease progression or intolerable adverse effects, death, withdrawal of informed consent or study termination.
Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m^2 ivgtt D1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Treatment-naive Diffuse Large B-cell Lymphoma | Experimental | Drug: Zanubrutinib, Polatuzumab Vedotin, RituximabElderly Treatment-naive Diffuse Large B-cell Lymphoma |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histopathologically confirmed DLBCL;
- Patients haven't received any anti-DLBCL therapy. Corticosteroids alone is not considered as a line of treatment;
- The age of patients ≥ 70 years old, or between 60 and 69 but with an ECOG score between 2-4;
- Patients intolerant to standard front-line therapy, i.e. R-CHOP, or R-miniCHOP etc.
- Good organ function;
Key exclusion criteria (16 listed)
- Patients with primary central nervous system lymphoma;
- Patients with previous exposure to BTK inhibitors;
- Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc; Currently clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or history of myocardial infarction within 6 months after screening. The left ventricular ejection fraction measured by echocardiography was < 50%;
- Abnormal laboratory indicators at screening (unless caused by lymphoma):
- 4.1 ANC<1.5×10^9/l, PLT<80×10^9/l 4.2 Coagulation function: INR greater than 1.5 times the upper limit of normal value; Pt and APTT were greater than 1.5 times the upper limit of normal 4.3 Liver function: ALT or ast was 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal 4.4 Renal function: creatinine was 1.5 times higher than the upper limit of normal, creatinine clearance rate was < 60 ml/min (estimated according to Cockcroft Gault formula)
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 |
|---|---|---|
| Zanubrutinib, Polatuzumab Vedotin, RituximabAlso: ZPRDrug: Zanubrutinib, Polatuzumab Vedotin and Rituximab Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab Vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m^2 ivgtt D1 | Drug | Elderly Treatment-naive Diffuse Large B-cell Lymphoma |
Primary outcome
ORR at the end of the 6th treatment cycle
Time frame: about six months from the start of ZPR
the proportion of participants who have achieved complete or partial remission determined by the researcher.
3 secondary outcomes
CRR at the end of the 6th treatment cycle
Time frame: about six months from the start of ZPR
Proportion of patients who have achieved 2-year PFS
Time frame: 2-year (from the start of treatment to the first recording of disease progression or death, based on the investigator's assessment of the first occurrence)
Safety evaluation
Time frame: between the first administration of the study drug and 30 days after discontinuation, or during the progression of the disease or the initiation of new anticancer treatment, whichever came first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Peng Liu, Ph.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib, Polatuzumab Vedotin, Rituximab in people with Diffuse Large B Cell Lymphoma, run by Peng Liu at 1 site 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 16 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: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR at the end of the 6th treatment cycle (time frame: about six months from the start of ZPR). 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 14 Oct 2026.