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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171899
First received: September 13, 2005
Last updated: November 14, 2012
Last verified: November 2012

September 13, 2005
November 14, 2012
April 2005
June 2007   (final data collection date for primary outcome measure)
Percent of patients achieving major molecular response at baseline and at last visit
Not Provided
Complete list of historical versions of study NCT00171899 on ClinicalTrials.gov Archive Site
  • Complete cytogenetic response at baseline and at last visit
  • Overall survival
  • Disease progression-free survival
  • Quality of Life assessment at baseline, last visit
  • Safety: adverse events and lab parameters, vital signs, physical exam, electrocardiogram, concomitant medications
Not Provided
Not Provided
Not Provided
 
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
Drug: imatinib mesylate
Experimental: STI571
Intervention: Drug: imatinib mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2007
June 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00171899
CSTI571ACA09
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP