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Clinical trial

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

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Last updated:1st Apr 2008
Identifier: NCT00651261

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.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)
Enrollment: 14
Study Start Date: April 2008
Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
Induction and consolidation chemotherapy plus midostaurin
- Active Comparator: Induction and consolidation chemotherapy plus placebo

Category Value
Date last updated at source 2017-02-06
Study type(s) Interventional
Expected enrolment 717
Study start date 2008-04-01
Estimated primary completion date 2016-07-01

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