Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)

Chronic Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171899
• Other study ID #: CSTI571ACA09
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 21, 2017
• Start date: April 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Toronto

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients achieving major molecular response at baseline and at last visit
Secondary	Complete cytogenetic response at baseline and at last visit
Secondary	Overall survival
Secondary	Disease progression-free survival
Secondary	Quality of Life assessment at baseline, last visit
Secondary	Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications

External Links

•   Results for CSTI571ACA09 from the Novartis Clinical Trials website