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

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

Completed

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Key information

Conditions

Chronic Myelogenous Leukemia in Chronic Phase Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

Patients who are pregnant or possibly pregnant
Significant hepatic diseases
Chronic Myelogenous Leukemia in advanced phase

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Imatinib

Drug

Primary outcomes

3 years overall survival
Duration of remaining in chronic phase

Secondary outcomes

Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
Adverse event

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start: 2002
Study completion: 2007
First posted: Oct 12, 2005
Registry last updated: Nov 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed