Pola-ZR-Glo for older patients with large B‑cell lymphoma
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 trial will try combining polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab as first-line treatment for people aged 70 and older with newly diagnosed large B‑cell lymphoma who are unfit for standard chemo or decline immunochemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | Polatuzumab, Glofitamab, Zanubrutinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07514169 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, open-label, single-arm Phase 2 study testing the Pola‑ZR‑Glo combination (polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab) in older, treatment‑naive patients with large B‑cell lymphoma. Eligible patients are aged 70 or older, classified as unfit or frail by comprehensive geriatric assessment or who decline standard immunochemotherapy, have ECOG 0–2, and measurable disease. Participants receive the combination regimen and are followed for tumor response and safety outcomes, including monitoring for treatment-related adverse events. All treatment and follow-up are conducted at Ruijin Hospital in Shanghai.
Who should consider this trial
Good fit: Ideal candidates are treatment‑naive patients aged 70 or older with histologically confirmed large B‑cell lymphoma, ECOG 0–2, classified as unfit or frail or who decline immunochemotherapy, with measurable disease and expected survival of at least three months.
Not a fit: Patients with prior anti-lymphoma therapy, central nervous system involvement, or those who are fit for and able to receive standard immunochemotherapy are unlikely to be appropriate candidates for this regimen.
Why it matters
Potential benefit: If successful, this regimen could offer an effective, less toxic first-line option for older patients with LBCL who cannot tolerate standard immunochemotherapy.
How similar studies have performed: Individual agents in the combination have shown activity in B‑cell lymphomas, but this specific four‑drug frontline approach in frail older patients is novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai
- Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weili Zhao
- Email: zwl_trial@163.com
- Phone: +862164370045 Ext. 610707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.