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

Novartis100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Myelogenous Leukemia in Chronic Phase

Interventions

ImatinibDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Outcomes

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

Data from ClinicalTrials.gov

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