Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called quizartinib (the study drug) for people with acute myeloid leukemia (AML) who do not have a FLT3-ITD mutation and who have not completed any treatment for their disease.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are newly diagnosed with AML
- Are receiving or plan to receive standard "7+3" induction chemotherapy regimen
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 study groups called arms:
- Arm A: If you take part in this arm, you will get the study drug for the whole study (together with chemotherapy in induction and consolidation, then only the study drug alone in maintenance).
- Arm B: If you take part in this arm, you will get a placebo (inactive substance with no drug in it) for the whole study (together with chemotherapy in induction and consolidation, then placebo alone in maintenance).
- Arm C: If you take part in this arm, you will get the study drug during the induction and consolidation period with chemotherapy, then placebo alone during the maintenance period.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY AND ADMINISTERED AS MAINTENANCE THERAPY IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD NEGATIVE
ACUTE MYELOID LEUKEMIA (QUANTUM-WILD)
ACUTE MYELOID LEUKEMIA (QUANTUM-WILD)
Principal Investigator
Harry
Erba
Protocol Number
PRO00116974
NCT ID
NCT06578247
Phase
III
Enrollment Status
Pending Open to Enrollment