Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2Pola-ZRCHPNCT07608978
Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes
A Phase 2 study testing POLA-R-CHP+Zanubrutinib in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- POLA-R-CHP+Zanubrutinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Phase 2
- 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
- Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD/BN2/N1 molecular subtypes defined by LymphGen classification.
- Previously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable lesion in two dimensions, defined as a maximum diameter >1.5 cm by CT or MRI.
- Left Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).
- Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product transfusions are allowed), defined as follows:
- Hemoglobin ≥9.0 g/dL within 7 days prior to first treatment, without packed RBC transfusion.
- Absolute Neutrophil Count (ANC) ≥1.0 × 10⁹/L. Platelet count ≥75 × 10⁹/L. Female participants of childbearing potential: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate ova.
- Male participants: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate sperm.
Who cannot join
- Contraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring within 4 weeks prior to the first dose of study treatment (as judged by the investigator).
- Suspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.
- History of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of results.
- Severe or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable arrhythmias; or unstable angina.
- Clinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.
- Any of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):
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- INR or PT >1.5 × Upper Limit of Normal (ULN) in the absence of therapeutic anticoagulation.
- PTT or aPTT >1.5 × ULN in the absence of lupus anticoagulant. Serum AST and ALT ≥2.5 × ULN. Total bilirubin ≥1.5 × ULN. Estimated creatinine clearance <40 mL/min (using the Cockcroft-Gault formula). Positive HBV DNA test result. Positive Hepatitis C test result (Hepatitis C virus [HCV] antibody serology). Note:Patients with positive HCV antibody are eligible only if the PCR test for HCV RNA is negative.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wei Xu, PhD contact
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
Jinhua Liang, MD, 15952032421, 1151525490@qq.com
Wei Xu, xuwei10000@hotmail.com
About this study
This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes.
After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT/PET-CT during treatment and after completion of induction. Patients who achieve CR/PR/SD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR/PR/SD) during induction will discontinue the study. Patients with CR/PR/SD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.
Efficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression/relapse.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- POLA-R-CHP+Zanubrutinib
- 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.
POLA-R-CHP+ZanubrutinibDrug
Previously untreated DLBCL patients harboring MCD/BN2/N1 subtypes were treated with Pola-ZRCHP (Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone，6 cycles, 21-day cycles), with Rituximab administered for 8 cycles. The regimen consisted of Polatuzumab vedotin (1.8 mg/kg IV, D1), Zanubrutinib (160 mg PO BID), and standard CHP (C 750 mg/m², H 50 mg/m² IV D1; P 100 mg PO D1-5). Following induction, patients achieving ≥Stable Disease (SD) per PET-CT entered the maintenance phase with Zanubrutinib (160 mg PO BID) and Tislelizumab (200 mg IV Q3W, up to 1 year), continuing until progression or unacceptable toxicity. Non-responders (<SD) discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Pola+ZRCHP | Experimental | Previously untreated DLBCL patients harboring MCD/BN2/N1 subtypes were treated with Pola-ZRCHP (Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone，6 cycles, 21-day cycles), with Rituximab administered for 8 cycles. The regimen consisted of Polatuzumab vedotin (1.8 mg/kg IV, D1), Zanubrutinib (160 mg PO BID), and standard CHP (C 750 mg/m², H 50 mg/m² IV D1; P 100 mg PO D1-5). Following induction, patients achieving ≥Stable Disease (SD) per PET-CT entered the maintenance phase with Zanubrutinib (160 mg PO BID) and Tislelizumab (200 mg IV Q3W, up to 1 year), continuing until progression or unacceptable toxicity. Non-responders (<SD) discontinued. Receives: Drug: POLA-R-CHP+Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Event-Free Survival rate（EFS）
The duration from the start of treatment to the first occurrence of disease progression (per the 2014 Lugano Classification), relapse, initiation of new anti-lymphoma therapy, or death from any cause. EFS will be estimated using the Kaplan-Meier method, and between-arm comparisons will be conducted via the log-rank test. Participants who have not experienced any of these events by the end of follow-up will be censored at their last documented disease-evaluation date.
Measured: Up to 2 years after start of treatment.
Secondary outcomes (4)
Complete response rate (CRR)
The proportion of evaluable participants who achieve complete response (CR) following 6 cycles of induction therapy. CR is defined in accordance with the 2014 Lugano Classification for Lymphoma: this requires the complete disappearance of all measurable/evaluable lymphoma lesions, resolution of all disease-related clinical symptoms, and normalization of imaging findings (e.g., no residual measurable disease on CT/MRI, and no metabolically active disease on FDG-PET/CT). The analysis population is restricted to participants who complete at least 4 cycles of induction therapy and have available post-treatment efficacy assessment data.
Measured: Within 21 days after the completion of the 6th cycle of induction therapy (Each cycle is 21 days)
Objective response rate (ORR)
The proportion of evaluable participants who achieve objective response (defined as complete response [CR] or partial response [PR]) following 6 cycles of induction therapy. Response assessment adheres to the 2014 Lugano Classification for Lymphoma: PR requires a ≥50% reduction in the sum of the longest diameters of measurable lesions, with no new lesions or progression of existing non-measurable disease. The analysis population includes participants who complete at least 4 induction cycles and have available post-treatment efficacy evaluation data.
Measured: Within 21 days after the completion of the 6th cycle of induction therapy At the end of Cycle 1 (each cycle is 21 days)
2-Year Overall Survival (OS)
The duration from randomization to death from any cause. OS will be estimated using the Kaplan-Meier method, with between-arm comparisons performed using the log-rank test. Participants who remain alive at the 2-year follow-up endpoint will be censored at their last confirmed survival date.
Measured: Up to 2 years after start treatment
Incidence of Treatment-Related Adverse Events (TRAE)
The proportion of participants experiencing any treatment-related adverse event, graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. This includes the incidence of grade 3-4 TRAEs and serious adverse events (SAEs; defined as events that are life-threatening, require hospitalization, result in persistent disability, or are fatal).
Measured: From the first dose of study intervention to 30 days after the last dose of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
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 Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT/PET-CT during treatment and after completion of induction. Patients who achieve CR/PR/SD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR/PR/SD) during induction will discontinue the study. Patients with CR/PR/SD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Xu, PHD, Principal investigator, Hematological Department, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608978
- Sponsor's protocol ID
- 2026-SR-137
- Acronym
- Pola-ZRCHP
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes
- ClinicalTrials.gov ID
- NCT07608978
- Acronym / sponsor ID
- Pola-ZRCHP / 2026-SR-137
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 May 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.
This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes.
After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT/PET-CT during treatment and after completion of induction. Patients who achieve CR/PR/SD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR/PR/SD) during induction will discontinue the study. Patients with CR/PR/SD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.
Efficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression/relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD/BN2/N1 Subtypes After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT/PET-CT during treatment and after completion of induction. Patients who achieve CR/PR/SD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR/PR/SD) during induction will discontinue the study. Patients with CR/PR/SD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.
| Arm | Type | Receives |
|---|---|---|
| Pola+ZRCHP | Experimental | Drug: POLA-R-CHP+ZanubrutinibPreviously untreated DLBCL patients harboring MCD/BN2/N1 subtypes were treated with Pola-ZRCHP (Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone，6 cycles, 21-day cycles), with Rituximab administered for 8 cycles. The regimen consisted of Polatuzumab vedotin (1.8 mg/kg IV, D1), Zanubrutinib (160 mg PO BID), and standard CHP (C 750 mg/m², H 50 mg/m² IV D1; P 100 mg PO D1-5). Following induction, patients achieving ≥Stable Disease (SD) per PET-CT entered the maintenance phase with Zanubrutinib (160 mg PO BID) and Tislelizumab (200 mg IV Q3W, up to 1 year), continuing until progression or unacceptable toxicity. Non-responders (<SD) discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD/BN2/N1 molecular subtypes defined by LymphGen classification.
- Previously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable lesion in two dimensions, defined as a maximum diameter >1.5 cm by CT or MRI.
- Left Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).
- Adequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product transfusions are allowed), defined as follows:
- Hemoglobin ≥9.0 g/dL within 7 days prior to first treatment, without packed RBC transfusion.
Key exclusion criteria (9 listed)
- Contraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring within 4 weeks prior to the first dose of study treatment (as judged by the investigator).
- Suspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.
- History of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of results.
- Severe or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable arrhythmias; or unstable angina.
- Clinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.
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 |
|---|---|---|
| POLA-R-CHP+ZanubrutinibPreviously untreated DLBCL patients harboring MCD/BN2/N1 subtypes were treated with Pola-ZRCHP (Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone，6 cycles, 21-day cycles), with Rituximab administered for 8 cycles. The regimen consisted of Polatuzumab vedotin (1.8 mg/kg IV, D1), Zanubrutinib (160 mg PO BID), and standard CHP (C 750 mg/m², H 50 mg/m² IV D1; P 100 mg PO D1-5). Following induction, patients achieving ≥Stable Disease (SD) per PET-CT entered the maintenance phase with Zanubrutinib (160 mg PO BID) and Tislelizumab (200 mg IV Q3W, up to 1 year), continuing until progression or unacceptable toxicity. Non-responders (<SD) discontinued. | Drug | Pola+ZRCHP |
Primary outcome
2-year Event-Free Survival rate（EFS）
Time frame: Up to 2 years after start of treatment.
The duration from the start of treatment to the first occurrence of disease progression (per the 2014 Lugano Classification), relapse, initiation of new anti-lymphoma therapy, or death from any cause. EFS will be estimated using the Kaplan-Meier method, and between-arm comparisons will be conducted via the log-rank test. Participants who have not experienced any of these events by the end of follow-up will be censored at their last documented disease-evaluation date.
4 secondary outcomes
Complete response rate (CRR)
Time frame: Within 21 days after the completion of the 6th cycle of induction therapy (Each cycle is 21 days)
Objective response rate (ORR)
Time frame: Within 21 days after the completion of the 6th cycle of induction therapy At the end of Cycle 1 (each cycle is 21 days)
2-Year Overall Survival (OS)
Time frame: Up to 2 years after start treatment
Incidence of Treatment-Related Adverse Events (TRAE)
Time frame: From the first dose of study intervention to 30 days after the last dose of study intervention
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 27 May 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.
Wei Xu, PhD contact
Wei Xu, PHD principal investigator
Hematological Department, Jiangsu Province Hospital
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 POLA-R-CHP+Zanubrutinib in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by The First Affiliated Hospital with Nanjing Medical University 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 27 May 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?
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 Jinhua Liang, MD (15952032421, 1151525490@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Event-Free Survival rate（EFS） (time frame: Up to 2 years after start of treatment.). 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 27 May 2026.