The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL (NCT07514169) | Clinical Trial Compass
RecruitingPhase 2
The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
China30 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range70 Years
SexALL
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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)…
What they're measuring
1
Progression free survival
Timeframe: Baseline up to data cut-off (up to approximately 2 years)