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A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)

Primary Objective The primary objective for the trial is to compare the progression free survival (PFS) of the time limited administration of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age. Secondary Objectives Evaluate overall survival (OS) of patients based on treatment arm. Monitor and assess toxicity of treatment based on treatment arm. Compare Minimal Residual Disease (MRD) status as assessed by flow cytometry at baseline and then sequentially during treatment of the two treatment arms. Accordingly, MRD assessment on BM will be limited to the end of cycle 19 response evaluation while MRD assessment on peripheral blood will occur on samples collected at 24, 30, 36, 48, and 60 months from randomization. Collect baseline and response evaluation (after cycle 19) bone marrow and paired blood specimens for evaluation of MRD. QOL Objectives To compare quality of life (QOL) in CLL patients during the first 19 cycles of treatment among patients on each treatment arm. To compare QOL over the long-term in CLL patients receiving continuous therapy using Ibrutinib to that of CLL patients who completed time limited therapy. Evaluate adherence to therapy for the two arms (one of which requires more intense, but shorter duration treatment, and one of which requires less intense, but indefinite duration therapy) and explore how adherence in each arm relates to PFS. Exploratory Tobacco Use Objectives To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events (both clinical and hematologic) and dose modifications). To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

Primary Objective The primary objective for the trial is to compare the progression free survival (PFS) of the time limited administration of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age. Secondary Objectives Evaluate overall survival (OS) of patients based on treatment arm. Monitor and assess toxicity of treatment based on treatment arm. Compare Minimal Residual Disease (MRD) status as assessed by flow cytometry at baseline and then sequentially during treatment of the two treatment arms. Accordingly, MRD assessment on BM will be limited to the end of cycle 19 response evaluation while MRD assessment on peripheral blood will occur on samples collected at 24, 30, 36, 48, and 60 months from randomization. Collect baseline and response evaluation (after cycle 19) bone marrow and paired blood specimens for evaluation of MRD. QOL Objectives To compare quality of life (QOL) in CLL patients during the first 19 cycles of treatment among patients on each treatment arm. To compare QOL over the long-term in CLL patients receiving continuous therapy using Ibrutinib to that of CLL patients who completed time limited therapy. Evaluate adherence to therapy for the two arms (one of which requires more intense, but shorter duration treatment, and one of which requires less intense, but indefinite duration therapy) and explore how adherence in each arm relates to PFS. Exploratory Tobacco Use Objectives To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events (both clinical and hematologic) and dose modifications). To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.