An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia
Status:
Terminated
Trial end date:
2020-08-20
Target enrollment:
Participant gender:
Summary
This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo
with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly
diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and
cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy
due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of
two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control
group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk
category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category
Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based
on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times
a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of
each cycle. Study treatment should continue until there is documented disease progression,
relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may
be required to achieve a complete remission. Once permanently discontinued from study
treatment, patients will enter the Long-term Follow-up phase of the study and will be
followed for assessment of disease progression, if applicable, and survival every 3 months
(±1 month) until death. The end of this study is defined when 390 events (deaths) have
occurred and the study is unblinded for final overall survival analysis. Patients who are
receiving study treatment at the end of the study may have the opportunity to continue to
receive the study drugs to which they were randomized to (Post- Study Observation Period),
until the Sponsor informs the Investigators of the appropriate course of action based on the
study results. The Post-Study Observation Period is defined as the period starting from the
end of the study for a maximum of 12 months.