Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00124748

Purpose

This study will investigate safety and efficacy of 400mg and 800mg imatinib in comparison, using molecular endpoints.

Condition	Intervention	Phase
Leukemia, Myeloid, Chronic Phase	Drug: Imatinib mesylate	Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Determine rate of hematologic response
Determine rate of complete cytogenetic response
Evaluate the time to major molecular response and complete molecular response
Compare percentage of patients with major molecular response and with undeetectable leves at 12 months and yearly thereafter
To evaluate progression free survival at 5 years

Estimated Enrollment:	420
Study Start Date:	June 2005

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Any prior treatment for CML (including Imatinib or interferon-alpha; hydroxyurea and/or anagrelide are allowed)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124748

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Novartis Clinical Trials Listing This link exits the ClinicalTrials.gov site

Study ID Numbers:	CSTI571K2301
Study First Received:	July 27, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00124748
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

CML
Philadelphia positive
Bcr-abl
imatinib mesylate
Chronic myeloid leukemia (CML) in chronic phase

Study placed in the following topic categories:

Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009