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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00237120
• Collaborator: (none)
• Enrollment: 100
• Duration (Months): 55

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia in Chronic Phase	Drug: Imatinib	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
• Study Start Date: Nov 1, 2002
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. 3 years overall survival []

2. Duration of remaining in chronic phase []

Secondary Outcome Measures

1. Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib, []

2. Adverse event []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis, Novartis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00237120
• Other Study ID Numbers: CSTI571AJP02
• First Posted: Oct 12, 2005
• Last Update Posted: Nov 23, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Chronic Myelogenous Leukemia; Imatinib; CML
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Imatinib Mesylate

Study Results

No Results Posted as of Nov 23, 2009