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Idarubicin and Cytarabine in Newly Diagnosed AML
NCT00422591Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Jan 2017
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- idarubicincytarabine
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of idarubicin and cytarabine in acute myeloid leukemia (AML), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Complete Response Rate at 2 months. Started Dec 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Idarubicin + Cytarabine
Standard combination chemotherapy with Idarubicin and Cytarabine.
03
Who it enrols
Patients aged 15-75 with newly diagnosed AML (>= 20% blasts) who are chemo-naive. Patients with M6 AML with < 20% blasts are eligible. Excludes APL and active systemic infection.
04
Endpoints
Primary
Complete Response Rate
Secondary
Event-Free Survival
Overall Survival
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