Trials / Completed
CompletedNCT00514488
Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)
A Phase III Study Comparing Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) in the Treatment of Newly Diagnosed High Risk Chronic Myeloid Leukemia in Chronic Phase
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- University of Bologna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | STI571 (400 mg/day; or 800 mg/day) |
Timeline
- Start date
- 2004-06-01
- First posted
- 2007-08-10
- Last updated
- 2007-08-10
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00514488. Inclusion in this directory is not an endorsement.