Status:

COMPLETED

Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)

Lead Sponsor:

Novartis

Conditions:

Chronic Myelogenous Leukemia in Chronic Phase

Eligibility:

All Genders

15-74 years

Phase:

PHASE3

Brief Summary

This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.

Eligibility Criteria

Inclusion

  • Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
  • Previously untreated with Interferon-alpha
  • Performance status is normal or capable of only limited self-care

Exclusion

  • Patients who are pregnant or possibly pregnant
  • Significant hepatic diseases
  • Chronic Myelogenous Leukemia in advanced phase
  • Other protocol-defined inclusion/exclusion criteria may apply.

Key Trial Info

Start Date :

November 1 2002

Trial Type :

INTERVENTIONAL

End Date :

June 1 2007

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00237120

Start Date

November 1 2002

End Date

June 1 2007

Last Update

November 23 2009

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