Actively Recruiting
The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
Led by Ruijin Hospital · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically-confirmed large B-cell lymphoma without central nervous system involvement
- Age 70 years or older and classified as unfit or frail by geriatric assessment, or decline immunochemotherapy
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- At least one measurable disease site with specified size criteria
- Life expectancy of at least 3 months
- Provide written informed consent prior to any special examination or procedure
- No prior use of anti-lymphoma drugs except glucocorticoids
You will not qualify if you...
- Uncontrolled blood clotting disorders, connective tissue diseases, serious infections, or other diseases
- Laboratory values showing neutrophils less than 1.0 x 10^9/L, platelets less than 75 x 10^9/L, ALT or AST 2.5 times above normal, serum bilirubin 1.5 times above normal, or eGFR below 30 ml/min/1.73m^2 unless caused by lymphoma
- Uncontrolled or significant cardiovascular diseases including left ventricular ejection fraction below 50%, cardiomyopathy, clinically significant QTc prolongation, or advanced atrioventricular block
- Positive hepatitis B surface antigen (HbsAg) patients must have HBV DNA below 1.0 x 10^3 IU/ml before enrollment; those negative for HbsAg but positive for HBcAb must also have HBV DNA below 1.0 x 10^3 IU/ml
- Known psychiatric disorders or inability to comply fully with the study protocol
- HIV infection
- History of stroke or brain bleeding within 6 months prior to therapy
- Other medical conditions assessed by researchers as impacting study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China, 200020
Actively Recruiting
Research Team
W
Weili Zhao
CONTACT
P
Pengpeng Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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