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active malignancy within 3 years.
Patients received no more than
three previous myelosuppressive
regimens and had not received
a monoclonal antibody for CLL
within 8 weeks prior to venetoclax
dosing, an anticancer therapy
within 14 days, or an antileukemic
steroid therapy within 7 days.
Venetoclax was administered
daily with a stepwise escalation
from 200-600 mg. One week after
the target dose of venetoclax was
achieved, rituximab 375 mg/m 2
was administered during the first
month and titrated to 500 mg/m 2
for months 2-6. Per study proto-
col, patients continued venetoclax
monotherapy until unacceptable
toxicity, disease progression, or
drug cessation. The maximum
tolerated dose of venetoclax was
not identified, and a 400 mg dose
was recommended for phase II of
the study.
Between August 6, 2012, and
May 28, 2014, 49 patients were
enrolled (41 in the dose-escalation
cohort and 8 in the safety expan-
sion cohort). As of data cutoff
(March 4, 2016), 31 patients
(63%) remained on the study. The
median follow-up was 28 months
(range = <1-42 months) for all
patients and 29 months (range =
21-42 months) for patients still
on the study. Eighteen patients
discontinued treatment for the
following reasons: disease pro-
gression (n=11), toxicity (n=3),
withdrawal of consent (n=3), and
loss to follow-up (n=1).
The most common adverse
events (AEs) were grade 1/2