The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
Recruiting
Phase 2Interventional Study
Large B-Cell Lymphoma (LBCL)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
70 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Ruijin Hospital · Other
Who this trial is looking for
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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.
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Status
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 wh…
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
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