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:
Novartis Pharmaceuticals
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelogenous Leukemia |
Drug: imatinib mesylate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Ph+ CML |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Percent of patients achieving major molecular response at baseline and at last visit
Secondary Outcome Measures:
- 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
| Enrollment: | 80 |
| Study Start Date: | April 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: STI571 | Drug: imatinib mesylate |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00171899 History of Changes |
| Other Study ID Numbers: | CSTI571ACA09 |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Novartis:
|
Chronic Myelogenous Leukemia Complete cytogenetic response Imatinib mesylate Major molecular response Chronic phase Ph+ Chronic Myelogenous Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic |
Chromosome Aberrations Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013