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Gleevec and Arsenic Trioxide in CML
NCT00250042Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2004
- Primary completion
- Apr 2005
- Countries
- 1
- Modality
- DNA Intercalators/Alkylators
- Drugs
- arsenic trioxide
- Conditions
- chronic myelogenous leukemia (CML)
01
Overview
Phase 2, open-label, single-arm trial of arsenic trioxide in chronic myelogenous leukemia (CML), sponsored by New Mexico Cancer Research Alliance. Primary endpoint: Activity of Arsenic Trioxide in Combination with Imatinib at 2 years. Started Apr 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Gleevec and Arsenic Trioxide
Imatinib 800 mg/d + Arsenic Trioxide for 16 weeks, followed by Imatinib maintenance
03
Who it enrols
Adult patients with CML in chronic phase who failed to achieve a complete response to first-line imatinib therapy, with adequate organ function and ECOG PS 0-2.
04
Endpoints
Primary
Activity of Arsenic Trioxide in Combination with Imatinib
Secondary
Toxicity Associated with Therapy
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