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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Myelogenous Leukemia in Chronic Phase

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00237120

CSTI571AJP02

Details and patient eligibility

About

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

Sex: All

Ages: 15 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)