The Efficacy and Safety of Pola-ZR2 Versus ZR2 in the Treatment of Old Patients With de Novo Diffuse Large B-cell Lymphoma
NCT Number: NCT06522555
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Interventions: DRUG: polatuzumab vedotin, zanubrutinib, rituximab and lenalidomide|DRUG: zanubrutinib, rituximab and lenalidomide
Sponsor: Ruijin Hospital
Sex: ALL
Age: OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2029-08-10
Locations: Shanghai Institute of Hematology, Rui-Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China

Summary:
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of Pola-ZR2 (polatuzumab vedotin, zanubrutinib, rituximab and lenalidomide) versus ZR2 (zanubrutinib, rituximab and lenalidomide) in the treatment of old patients with de novo diffuse large B-cell lymphoma

Primary Outcome Measures: 2-year PFS rate, up to approximately 2 years
Secondary Outcome Measures: Progression free survival, Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first., Baseline up to data cut-off (up to approximately 2 years)|2-year OS rate, 2-year OS rate, Baseline up to data cut-off (up to approximately 2 years)|Overall survival, Overall survival was defined as the time from the date of randomization to the date of death from any cause., Baseline up to data cut-off (up to approximately 2 years)|Complete response rate, Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria., End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]|Overall response rate, Percentage of participants with complete or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria., End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]|Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events., From enrollment to study completion, a maximum of 5 years|Percentage of Participants Achieving Meaningful Improvement in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), Quality of Life will be assessed by EORTC QLQ-C30 (Verison 3.0)., Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion|Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-ELD14 (Elderly Module), Quality of Life will be assessed by EORTC QLQ-ELD14., Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion|Percentage of Participants Achieving Meaningful Improvement in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS), Quality of Life will be assessed by FACT-Lym LymS., Day 1 of Cycles 1 and 4 (Cycle length=21 days); 30 days after treatment completion