A phase III, randomized, double-blind study of
chemotherapy with daunorubicin or idarubicin and
cytarabine for induction and intermediate dose cytarabine
for consolidation plus midostaurin (PKC412) or
chemotherapy plus placebo in newly diagnosed patients
with FLT-3 mutation negative acute myeloid leukemia (AML)
This study is being done to answer the following question:
Is the drug midostaurin used in combination with standard chemotherapy treatment safe and does it have beneficial effects in people who have newly diagnosed acute myeloid leukemia (AML) without FLT3 mutation (FLT3-mutation negative, FLT3-MN)?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your AML. The usual approach is defined as care most people get for AML.
In this study, we will learn about a drug called midostaurin (the study drug). We do not know if the study drug works. The study drug has been approved by the FDA for newly diagnosed AML who are FLT3 mutation-positive, but not for newly diagnosed AML who are FLT3 mutation-negative.
Daunorubicin/idarubicin and cytarabine are drugs that are not made by Novartis. These drugs have been approved by the FDA.
Acute myeloid leukemia (AML) without FLT3 mutation (FLT3-mutation negative, FLT3-MN)
Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have been diagnosed with AML,
Your disease has been untreated, and
-Documented absence of the FLT3 gene.
18 - N/A
Healthy Volunteers Needed
Duration of Participation
Your study participation may last about 17 to 20 months for the study treatment phase if you complete full treatment. After the study treatment is completed, you will be followed for safety evaluations and the course of your disease including further treatments if required for up to 5 years after the end of study treatment of last subject. Follow-up will either be conducted during clinic visits or by telephone every 3 months or have a study visit to follow up on your survival status.
Clinical Trials Information Line
Novartis Pharmaceuticals Corporation