A RANDOMIZED PHASE III STUDY OF IBRUTINIB PLUS OBINUTUZUMAB VERSUS IBRUTINIB PLUS VENETOCLAX AND OBINUTUZUMAB IN UNTREATED OLDER PATIENTS (>/= 70 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)
Current Status: Open to accrual
Phase: III
Principal Investigator: Bociek, R Gregory
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03737981?cond=NCT03737981&draw=2&rank=1#eligibility
Summary
Primary Objective: To compare the progress-free survival (PFS) between control treatment and experimental treatment strategies: ibrutinib/obinutuzumab (IO) with ibrutinib maintenance (IM) versus ibrutinib/venetoclax/obinutuzumab (IVO) regardless of IM or observation. Secondary Objectives: to compare BM MRD-CR rates, MRD rates, and depth of response at Cycle 15 Day 1 between patients treated with IO versus IVO; to compare overall survival (OS) between the control and experimental treatment strategies: IO with IM versus IVO regardless of IM or observation; to compare the 5-year PFS and OS for the control and experimental treatment strategies: IO with IM versus IVO regardless of IM or observation; to describe the toxicity profile for each of the treatment strategies and by each treatment course. Correlative science objectives: To compare MRD status between blood and bone marrow at the end of induction treatment/Cycle 15 Day 1 to determine whether blood MRD can be used as a surrogate to bone marrow MRD with these treatment regimens.