A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy + midostaurin (PKC 412) (IND # 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML) - CPKC412A2301

Phase 1

• Conditions: newly diagnosed FLT3 mutated acute myeloid leukemia; MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-23
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 714

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 section 4)
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 714
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
- Total bilirubin >= 2.5x upper limit of normal
- Pregnant or nursing patients

Study & Design

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