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Gleevec in early chronic phase CML
NCT00048672Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2001
- Primary completion
- Nov 2002
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- imatinib
- Conditions
- chronic myeloid leukemia (CML)
01
Overview
Phase 2, open-label, single-arm trial of imatinib in chronic myeloid leukemia (CML), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Complete Cytogenetic Response at 12 months. Started Mar 2001; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Gleevec
Gleevec 400 mg orally daily
03
Who it enrols
Patients with Ph-positive or bcr-positive CML in early chronic phase (diagnosis < 12 months), aged 15 years or older, with adequate organ function and performance status. Excludes patients with Grade 3-4 cardiac issues or psychiatric problems.
04
Endpoints
Primary
Complete Cytogenetic Response
Secondary
Duration of Cytogenetic Response
Duration of Hematologic Response
Overall Survival
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