Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

This study is ongoing, but not recruiting participants.

First Received on March 19, 2008. Last Updated on November 23, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00644878

Purpose

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Condition	Intervention	Phase
Chronic Myelogenous Leukemia - Chronic Phase	Drug: Nilotinib	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome tetrasomy 18p

MedlinePlus related topics: Chronic Myeloid Leukemia Leukemia

Drug Information available for: Imatinib Imatinib mesylate AMN 107

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Bcr-Abl levels measured by polymerase chain reaction testing [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of major molecular response, measured by PCR [ Time Frame: yearly ] [ Designated as safety issue: No ]
Rate of log reduction in Bcr-Abl transcripts, measured by PCR [ Time Frame: yearly ] [ Designated as safety issue: No ]
Time to and duration of the best molecular response, measured by PCR [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nilotinib	Drug: Nilotinib Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose. Other Names: Nilotinib Tasigna AMN 107

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Select Inclusion Criteria:

Male or female patients
18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR
Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months for Group 1 patients)
A suboptimal molecular response to imatinib defined as:
- Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels >0.1%IS);
- Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels
Adequate end organ function

Select Exclusion Criteria:

Prior accelerated phase or blast crisis CML
Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study
Previously documented T315I mutations
Prior therapy with any other tyrosine kinase inhibitor except imatinib
Patients with contraindications to receiving nilotinib, including concomitant medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644878

Show 26 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00644878 History of Changes
Other Study ID Numbers:	CAMN107AUS09
Study First Received:	March 19, 2008
Last Updated:	November 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

leukemia
chronic myelogenous leukemia
chronic phase

molecular response
nilotinib
ENABL

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic

Chromosome Aberrations
Pathologic Processes
Disease Attributes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012