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High-Dose Chemo, Auto-SCT, and IL-2 in AML
NCT00002945Phase 3
Key facts
- Status
- Completed
- Start
- Dec 1996
- Primary completion
- Aug 2001
- Countries
- 1
- Modality
- Cytokines & Interferons
- Drugs
- aldesleukin
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 3, open-label, single-arm trial of aldesleukin in acute myeloid leukemia (AML), sponsored by Roswell Park Comprehensive Cancer Center. Primary endpoint: Relapse Free Survival. Started Dec 1996; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment Arm
High-dose chemo induction/intensification, Auto-SCT, and IL-2 maintenance
03
Who it enrols
Adults over 25 with previously untreated de novo or secondary AML (excluding M3/promyelocytic). Must have adequate organ function (LVEF >= 45%, normal/near-normal liver and renal function). No prior chemotherapy for leukemia allowed.
04
Endpoints
Primary
Relapse Free Survival
Secondary
Remission Rate
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