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

Chronic Myelogenous Leukemia in Chronic Phase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237120
• Other study ID #: CSTI571AJP02
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: November 20, 2009
• Start date: November 2002
• Est. completion date: June 2007

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia in Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Imatinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 years overall survival
Primary	Duration of remaining in chronic phase
Secondary	Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
Secondary	Adverse event