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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00237120

Enrollment

100

Registered

2005-10-12

Start date

2002-11-30

Completion date

2007-06-30

Last updated

2009-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia in Chronic Phase

Keywords

Chronic Myelogenous Leukemia, Imatinib, CML

Brief summary

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

Interventions

DRUGImatinib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 74 Years

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/

Design outcomes

Primary

Measure	Time frame
3 years overall survival	—
Duration of remaining in chronic phase	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026