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chronic lymphocytic leukemia
This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax
work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of
cancer cells by blocking some of the enzymes needed for cell growth. Obinutuzumab is a
monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.
Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer
cell survival. Giving ibrutinib, obinutuzumab, and venetoclax may work better than giving
ibrutinib and obinutuzumab in treating patients with chronic lymphocytic leukemia.
I. 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 chronic lymphocytic leukemia (CLL) patients younger than 70 years of age.
I. Evaluate overall survival (OS) of patients based on treatment arm. II. Monitor and assess
toxicity of treatment based on treatment arm. III. Compare minimal residual disease (MRD)
status as assessed by flow cytometry at baseline and then sequentially during treatment of
the two treatment arms.
IV. Collect baseline and response evaluation (after cycle 19) bone marrow and paired blood
specimens for evaluation of MRD.
QUALITY OF LIFE (QOL) OBJECTIVES:
I. To compare quality of life (QOL) in CLL patients during the first 19 cycles of treatment
among patients on each treatment arm.
II. 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.
III. 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 progression-free survival (PFS).
EXPLORATORY TOBACCO USE OBJECTIVES:
I. 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
II. To determine the effects of tobacco on patient-reported physical symptoms and
III. To examine quitting behaviors and behavioral counseling/support and cessation medication
IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose
intensity, and therapeutic benefit.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive ibrutinib orally (PO) daily on days 1-28 and obinutuzumab
intravenously (IV) over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles
2-6. Patients also receive venetoclax PO once daily (QD) on days 1-28 of cycles 3-14.
Treatment repeats every 28 days for up to 19 cycles in the absence of disease progression or
ARM B: Patients receive ibrutinib PO and obinutuzumab as in arm A. Cycles repeat every 28
days in the absence of disease progression or unacceptable toxicity.
All patients, including those who discontinue therapy early, are followed for response until
disease progression, even if non-protocol therapy is initiated. Patients are then followed
every 3 months for first 2 years, every 6 months for years 3-5, and then every 12 months for
years 6-10. All patients must also be followed through completion of all protocol therapy.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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