RecruitingRecruiting
The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
NCT07514169 · Ruijin Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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)
About this study
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.
Eligibility 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
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: older_adult
Timeline
Starts: 2026-03-31
Estimated completion: 2029-12-31
Last updated: 2026-05-08
Interventions
Drug: Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen
Primary outcomes
- • Progression free survival (Baseline up to data cut-off (up to approximately 2 years))
Sponsor
Ruijin Hospital · other
Contacts & investigators
ContactWeili Zhao · contact · zwl_trial@163.com · +862164370045 Ext. 610707
ContactPengpeng Xu · contact · pengpeng_xu@126.com · +862164370045 Ext. 610707
All locations (1)
Ruijin HospitalRecruiting
Shanghai, China