Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Trial ID or NCT#

NCT00651261

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.

Official Title

A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 59 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Jason Gotlib
Hematologist-Oncologist
Professor of Medicine (Hematology)
Caroline Berube
Caroline Berube
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology

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Contact

Cancer Clinical Trials Office
650-498-7061