The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL
ConditionLarge B-Cell Lymphoma (LBCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age70+
SponsorRuijin Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
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
Trial design
Design model
Single group
Treatments tested in this trial
Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen
DrugPola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 12 cycles. Dosage: Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6 (each Q3W). Zanubrutinib (160mg bid p.o.) will be administered from D1 to D21 through Cycles 1-6 Q3W. Lenalidomide (25mg qd p.o.) will be administered from D2 to D11 through Cycles 1-6 Q3W. Glofitamab will be administered i.v. on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2-12, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pola-ZR-GloExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival
Time frame
Baseline up to data cut-off (up to approximately 2 years)Secondary outcomes
1
Event-free survival
Time frame
Baseline up to data cut-off (up to approximately 2 years)2
Complete response rate
Time frame
At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)3
Objective response rate
Time frame
At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)4
Overall Survival
Time frame
Baseline up to data cut-off (up to approximately 2 years)Sponsors and contacts
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Source ClinicalTrials.gov