Quizartinib or placebo + chemotherapy in patients with FLT3-ITD- AML (Acute Myeloid Leukemia) - Clinical Trial
¿Cuál es el Propósito de este estudio?
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.
Newly Diagnosed Acute Myeloid Leukemia (AML)
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Are newly diagnosed with AML
- Are receiving or plan to receive standard "7+3" induction chemotherapy regimen
For more information, contact the study team at erin.murphy@duke.edu.
¿Qué Implica?
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.
You will have a 40% chance of being assigned to Arm A, a 40% chance of being assigned to Arm B, and a 20% chance of being assigned to Arm C.
If your doctor decides that you will benefit from a stem cell transplant, then you will get the transplant during the consolidation portion of the study regimen.
Detalles del Estudio
