Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, prospective, single-center interventional study evaluating a chemotherapy-light regimen that combines glofitamab, polatuzumab vedotin, and zanubrutinib (GPZ) for first-line treatment in patients aged 70 and older with untreated DLBCL. Eligible participants will receive the GPZ combination to assess its efficacy and safety in this specific population. The study has predefined eligibility criteria including adequate organ function and performance status, and requires informed consent. Outcomes focus on response rates, safety, and tolerability in the elderly newly diagnosed cohort. Lead institution is Shanghai Zhongshan Hospital with collaboration from Hoffmann-La Roche and BeiGene, conducted at Zhongshan Hospital, Fudan University, Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Subjects will only be included in the study if they meet all the following criteria:

1. Written informed consent.
2. Aged 70 years old or above.
3. ECOG performance status of 0-3.
4. Histologically confirmed CD20 positive DLBCL.
5. At least one measurable site of disease.
6. Patient did not receive any prior lymphoma therapy.
7. Patient has a life expectancy (in the opinion of the investigator) of at least 12 weeks.
8. 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.
9. 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.
10. 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.

Exclusion Criteria:

Subjects will not be included in the study if any of the following criteria apply:

1. 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%.;
2. Patient with current or history of CNS lymphoma.
3. 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.
4. Patient with current \> Grade 1 peripheral neuropathy.
5. 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
6. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
7. 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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Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Peng Liu — Fudan University
• Study coordinator: Peng Liu
• Email: liu.peng@zs-hospital.sh.cn
• Phone: +86-021-64041990

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.