CPX-351+GO in Subjects 55 Years Old, or Older, With AML
Status:
Recruiting
Trial end date:
2026-09-01
Target enrollment:
Participant gender:
Summary
This is an open label study to assess the safety and efficacy of CPX-351 in combination with
gemtuzumab ozogamicin (GO) as first intensive therapy in older (age >55 years) subjects with
newly diagnosed AML who are eligible for intensive induction chemotherapy, or AML subjects
who previously failed low-intensity therapy but who would be eligible for high-intensity
chemotherapy, with companion cognitive function testing to determine whether this contributes
to outcome in these subjects. Subjects may have received prior AML treatment with
non-intensive regimens, e.g. hypomethylating agents, low-dose cytarabine, or lenalidomide or
a clinical trial drug in combination with hypomethylating agents or low-dose cytarabine, but
may not have received intensive AML treatment with anthracyclines and/or infusional
cytarabine prior to enrollment on this trial. Subjects may not have been treated with GO or
other antibody targeting CD 33 prior to enrollment on this trial. The cohort will include 30
subjects treated with the combination of CPX-351 and GO and is designed to establish the
safety and feasibility of the combination. These subjects will be assessed for efficacy and
safety. Quality of life will be assessed using the FACT-LEU in all subjects. Cognitive
function will be assessed using the Blessed Orientation-Memory-Concentration Test and the
Montreal Cognitive Assessment.