The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL (SILVERGLO)

May 5, 2026 updated by: Zhao Weili, Ruijin Hospital

The Efficacy and Safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) Regimen in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)

This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen in older treatment-naive patients with large B-cell lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200020
        • Recruiting
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients must satisfy all of the following criteria to be enrolled in the study:

  • Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)
  • Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.
  • Eastern Cooperative Oncology Group Performance Status 0-2
  • At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
  • Life expectancy of at least 3 months determined by researchers
  • The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
  • Anti-lymphoma drugs have not been used before (except glucocorticoids)

Exclusion Criteria:

Presence of any of the following criteria will exclude a patient from enrollment:

  • Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
  • Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

Neutrophils<1.0×10^9/L Platelets<75×10^9/L ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN.

eGFR is lower than 30ml/min/1.73m^2 (according to Cockcroft-Gault Equation or MDRD Equation).

  • uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block
  • Patients with HbsAg positive are required to have HBV DNA<1.0×10^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10^3 IU/ml is required before entering the group
  • Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
  • HIV-infected patients
  • History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
  • Other medical conditions determined by the researchers that may affect the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pola-ZR-Glo
Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab
Drug: Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen

Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 12 cycles.

Dosage:

Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6 (each Q3W).

Zanubrutinib (160mg bid p.o.) will be administered from D1 to D21 through Cycles 1-6 Q3W.

Lenalidomide (25mg qd p.o.) will be administered from D2 to D11 through Cycles 1-6 Q3W.

Glofitamab will be administered i.v. on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2-12, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
Baseline up to data cut-off (up to approximately 2 years)
Complete response rate
Time Frame: At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)
At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)
Objective response rate
Time Frame: At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)
At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)
Overall Survival
Time Frame: Baseline up to data cut-off (up to approximately 2 years)
Baseline up to data cut-off (up to approximately 2 years)
DoR
Time Frame: From documentation of CR/PR until relapse/progression or death due to any reason without documented relapse, whichever came first, assessed up to 32 months.
From documentation of CR/PR until relapse/progression or death due to any reason without documented relapse, whichever came first, assessed up to 32 months.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time Frame: From enrollment to study completion, a maximum of 4 years
From enrollment to study completion, a maximum of 4 years
Patient reported outcome
Time Frame: Day 1 of Cycles 1, 4 and 7 (Cycle length=21 days); 30 days after treatment completion
Quality of Life will be assessed by EORTC QLQ-C30 (Verison 3.0), EORTC QLQ-ELD14 and FACT-Lym LymS.
Day 1 of Cycles 1, 4 and 7 (Cycle length=21 days); 30 days after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SILVERGLO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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