Diffuse Large B-Cell LymphomaPhase 2NCT07012980
Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
A Phase 2 study testing Glofitamab, Polatuzumab Vedotin and Zanubrutinib in people with Diffuse Large B-Cell Lymphoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aims to assess the efficacy and safety of the chemotherapy-light combination of glofitamab, polatuzumab vedotin and zanubrutinib (GPZ) in elderly patients with previously untreated diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Glofitamab, Polatuzumab Vedotin and Zanubrutinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Jul 2027
- Phase
- Phase 2
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects will only be included in the study if they meet all the following criteria:
- Written informed consent.
- Aged 70 years old or above.
- ECOG performance status of 0-3.
- Histologically confirmed CD20 positive DLBCL.
- At least one measurable site of disease.
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- Patient did not receive any prior lymphoma therapy.
- Patient has a life expectancy (in the opinion of the investigator) of at least 12 weeks.
- Patient has adequate liver function:
- Total bilirubin ≤1.5 x ULN (≤3 x ULN in patients with Gilbert's syndrome).
- AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤3 x ULN. o Patients with documented liver involvement: AST and/or ALT ≤5 x ULN.
- Patient as adequate hematological function, unless due to lymphoma:
- Hemoglobin ≥9.0 g/dL within 7 days before the first treatment.
- Absolute neutrophil count of ≥1.0 x 109 cells/L (1,000/μL).
- Platelet count of ≥75 x 109 cells/L (75,000/μL). Note: Transfusion of RBCs and platelets is allowed to reach the inclusion criteria. In case screening procedures are leading to situations that would exclude the patient from study participation (such as Hb value below entry criteria), the patient may still be enrolled into the trial after consultation with the principal investigator.
- Patient has adequate renal function:
- Creatinine ≤ 1.5 x ULN, or
- Creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥ 30 mL/min for patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function.
Who cannot join
- Subjects will not be included in the study if any of the following criteria apply:
- History of severe cardiac disease: New York Heart Association (NYHA) grade 3-4, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
- Note: Congestive heart failure NYHA II patients can be included if they provide an LVEF >40%.;
- Patient with current or history of CNS lymphoma.
- Patient with uncontrolled severe infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus [EBV], cytomegalovirus [CMV], hepatitis B, hepatitis C, and HIV], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.
- Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
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- Patient with current > Grade 1 peripheral neuropathy.
- Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment
- Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
- Known hypersensitivity to Chinese hamster ovary (CHO) cell products or to any component of the zanubrutinib, polatuzumab vedotin, obinutuzumab, or glofitamab and/or to the contrast agents used in the study.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Yuhong Ren, 02164041990, ren.yuhong@zs-hospital.sh.cn
Peng Liu
About this study
Official title: Efficacy and Safety of Glofitamab, Polatuzumab Vedotin and Zanubrutinib in the First-line Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL): A Single-center, Single-arm, Prospective, Phase II Trial
This study aims to assess the efficacy and safety of the chemotherapy-light combination of glofitamab, polatuzumab vedotin and zanubrutinib (GPZ) in elderly patients with previously untreated diffuse large B-cell lymphoma.
Read the detailed description
This study is a prospective, single-center, interventional, phase 2 study. Each patient screend eligible for this study will receive a combination therapy of glofitamab, zanubrutinib and polatuzumab vedotin.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Glofitamab, Polatuzumab Vedotin, Zanubrutinib
- Keywords
- glofitamab, polatuzumab vedotin, zanubrutinib, first-line, elderly, frail
- 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.
GlofitamabDrug
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 2-6, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.
Polatuzumab VedotinDrug
Also called Polivy
Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of the subsequent Cycle 2-6 (each Q3W).
ZanubrutinibDrug
Zanubrutinib (160mg bid p.o.) will be administered for 7 days as pretreatment and from D1 to D21 through all 12 cycles Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab, polatuzumab vedotin and zanubrutinib | Experimental | 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 2-6, with each cycle being 21 days.
A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.
Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of the subsequent Cycle 2-6 (each Q3W).
Zanubrutinib (160mg bid p.o.) will be administered for 7 days as pretreatment and from D1 to D21 through all 12 cycles Q3W. Receives: Drug: Glofitamab; Drug: Polatuzumab Vedotin; Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS) rate
defined as the time from the day of inclusion until disease progression (PD) or relapse after complete remission (CR) as per Lugano Classification of 2014, or death due to any cause, whichever occurs first, at 12 months from the day of inclusion. Death due to any cause within 12 months is counted as an event.
Measured: From the day of inclusion until disease progression (PD) or relapse after complete remission (CR) as per Lugano Classification of 2014, or death due to any cause, whichever occurs first, assessed up to 39 months.
Secondary outcomes (3)
CR rate
defined as the number of patients achieving CR divided by the number of analyzable patients.
Measured: up to 12 cycles, an avergae of 11 months
DoR
defined as the time from documentation of CR/PR until relapse/progression or death due to any reason without documented relapse. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assess
Measured: From documentation of CR/PR until relapse/progression or death due to any reason without documented relapse. Assessed up to 39 months.
Incidence of treatment-related death rate
defined as the number of treatment related deaths during therapy or up to 2 months after the end of study treatment, but before the start of further treatment, divided by the number of analyzable patients.
Measured: defined as the number of treatment related deaths during therapy or up to 2 months after the end of study treatment, but before the start of further treatment, divided by the number of analyzable patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start20 Jun 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (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 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, BeiGene
- Responsible party
- Principal investigator, Peng Liu, Shanghai Zhongshan Hospital
- Investigators
- Peng Liu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012980
- Sponsor's protocol ID
- SHZS-DLBCL004
- Status last verified
- Oct 2026
- First submitted
- 24 May 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication