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Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day)

NCT00514488 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2007-08-10

No results posted yet for this study

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

  • Chronic Myeloid Leukemia

Interventions

DRUG

STI571 (400 mg/day; or 800 mg/day)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Bologna

    lead OTHER

Principal Investigators

  • Michele Baccarani, MD · Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00514488 on ClinicalTrials.gov