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chronic lymphocytic leukemia
This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual
treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia
who have not received previous treatment. The addition of venetoclax to the usual treatment
might prevent chronic lymphocytic leukemia from returning. This trial also will investigate
whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no
detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib.
Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell
growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may
interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,
such as venetoclax work in different ways to stop the growth of cancer cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving
ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic
leukemia compared to ibrutinib and obinutuzumab.
I. To compare the progression-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.
I. To compare bone marrow (BM) minimal residual disease (MRD)- complete response (CR) rates,
MRD- rates, and depth of response at cycle 15 day 1 between patients treated with IO versus
II. To compare overall survival (OS) between the control and experimental treatment
strategies: IO with IM versus IVO regardless of IM or observation.
III. To compare the 5-year PFS and overall survival (OS) for the control and experimental
treatment strategies: IO with IM versus IVO regardless of IM or observation.
IV. To describe the toxicity profile for each of the treatment strategies and by each
CORRELATIVES SCIENCE OBJECTIVE:
I. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Patients also
receive obinutuzumab intravenously (IV) on days 1, 2, 8, and 15 of cycle 1, and on day 1 of
cycles 2-6. Treatment repeats every 28 days for up to 14 cycles in the absence of disease
progression or unacceptable toxicity. Beginning cycle 15, patients receive ibrutinib PO QD
every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive ibrutinib PO QD on days 1-28. Patients also receive obinutuzumab IV
on days 1, 2, 8, and 15 of cycle 1, and on day 1 of cycles 2-6. Beginning cycle 3, patients
also receive venetoclax PO QD on days 1-28. Treatment repeats every 28 days for 14 cycles in
the absence of disease progression or unacceptable toxicity. All patients will then receive a
15th cycle of ibrutinib. Beginning cycle 16, patients who do not achieve a BM MRD negative
CR, receive ibrutinib PO QD every 28 days in the absence of disease progression or
unacceptable toxicity. Patients who achieve a BM MRD negative CR undergo observation every 3
cycles for 6 years, then every 6 cycles thereafter.
After completion of study treatment, patients are followed every 6 months until 10 years from
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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