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Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML


Phase 4
18 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

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Trial Information

Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML


Inclusion Criteria:



- Chronic myelogenous leukemia with Philadelphia chromosome

- 18 years and older

- Patients must have been taking imatinib mesylate standard dose for at least 12 months
and have achieved a complete cytogenetic response but not a major molecular response.

Exclusion Criteria:

- Patients with cardiac problems such as congestive heart failure, or myocardial
infarction within the last 6 months

- Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic
renal (kidney) disease or active uncontrolled infection.

- Patients with other current primary malignancy or malignancy requiring active
intervention

Other protocol defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percent of patients achieving major molecular response at baseline and at last visit

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Canada: Health Canada

Study ID:

CSTI571ACA09

NCT ID:

NCT00171899

Start Date:

April 2005

Completion Date:

June 2007

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Chronic Myelogenous Leukemia
  • Complete cytogenetic response
  • Imatinib mesylate
  • Major molecular response
  • Chronic phase Ph+ Chronic Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome

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