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) - CALGB10603/PKC412A2301

• Conditions: FLT3 mutated acute myeloid leukemia; MedDRA version: 9.1Level: LLTClassification code 10000886Term: Acute myeloid leukemia

• Registration Number: EUCTR2006-006852-37-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-14
• Last Update Posted: 8 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

- Unequivocal diagnosis of AML (> 20% blasts in the bone marrow based on the
WHO classification, excluding M3 (acute promyelocytic leukemia)
- Documented FLT3 mutation
- Age =18 and < 60 years
- No prior chemotherapy for leukemia or myelodysplasia with few exception listed
(see protocol page 7)
- Bilirubin < 2.5 upper limit of normal
- Non pregnant and non-nursing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients who have developed therapy related AML after prior RT or chemotherapy
for another disorder or cancer
- Patients with symptomatic congestive heart failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine if the addition of midostaurin to daunorubicin/cytarabine induction, high dose cytarabine consolidation and continuation therapy improves overall survival in both the mutant FLT3-ITD and FLT3-TKD AML patinets;Secondary Objective: - to compare the CR rate between the 3 treatment groups<br>- to compare the event-free survival (EFS) between the 2 treatment groups<br>- to compare the DFS of the 2 treatment groups<br>- to assess toxicity of experimental combination<br>- to assess population PK of midostaurin and its 2 major metabolites;Primary end point(s): Overall survival (OS)