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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pola-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.
Ruijin Hospital
Shanghai, China
Progression free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Event-free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Complete response rate
Time frame: At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)
Objective response rate
Time frame: At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)
Overall Survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
DoR
Time frame: From documentation of CR/PR until relapse/progression or death due to any reason without documented relapse, whichever came first, assessed up to 32 months.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time frame: From enrollment to study completion, a maximum of 4 years
Patient reported outcome
Quality of Life will be assessed by EORTC QLQ-C30 (Verison 3.0), EORTC QLQ-ELD14 and FACT-Lym LymS.
Time frame: Day 1 of Cycles 1, 4 and 7 (Cycle length=21 days); 30 days after treatment completion
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