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Genasense + Mylotarg in Elderly Relapsed AML
NCT00017589Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2000
- Countries
- 1
- Sponsor
- Genta Incorporated
- Modality
- Small Interfering RNA (siRNA), Modified DNA Oligonucleotides, Single-strand DNA
- Drugs
- oblimersen
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of oblimersen in acute myeloid leukemia (AML), sponsored by Genta Incorporated. Primary endpoint: Complete Response Rate. Started Dec 2000; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Oblimersen + Gemtuzumab Ozogamicin
Oblimersen sodium IV continuous infusion and Gemtuzumab ozogamicin IV infusion
03
Endpoints
Primary
Complete Response Rate
Secondary
Overall Response Rate
Duration of Response
Safety Profile
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