About this trial
This clinical trial is looking at a new drug called ziftomenib. It is being tested for people with acute myeloid leukemia (AML) who have specific genetic changes. The goal is to see if adding ziftomenib to standard treatments can improve outcomes for these patients. There are two parts to the study: one for older patients or those with other health issues, and another for medically fit patients.
The trial's ID number is NCT07007312. This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. It is regulated by the FDA, and the study hopes to include about 1,300 participants.
Who can join
This trial is open to adults aged 18 and older. It includes men and women with untreated AML who have certain genetic mutations. Some patients may not qualify if they have specific health problems or have received prior treatments for AML. The trial team will check to confirm if you are eligible to join.
Condition
Acute Myeloid Leukemia (AML)
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be assigned to one of several treatment groups by chance. Some will receive ziftomenib with standard treatments, while others will get a placebo instead of ziftomenib. This ensures that neither the patients nor the doctors know who is receiving the actual treatment. The study has two main groups: one for non-intensive therapy and another for intensive therapy.
Where
This trial is running at 42 locations in the United States. All of them are currently recruiting.
Banner MD Anderson Cancer Center
Gilbert, Arizona
Baptist Clinical Research Institute
Memphis, Tennessee
Cedars-Sinai Medical Center
Los Angeles, California
Colorado Blood Cancer Institute
Denver, Colorado
Columbia University
New York, New York
Duke University Medical Center
Durham, North Carolina
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin
Hartford HealthCare Cancer Institute
Hartford, Connecticut
The first 8 of 42 sites are listed here. The registry record has the full list.