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
Name: Nilotinib
Description: 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.Type: DrugNilotinib
Single Group Assignment
There is one SNP
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 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 Chronic Myelogenous Leukemia - Chronic Phase Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Philadelphia Chromosome null --- T315I ---
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 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 Chronic Myelogenous Leukemia - Chronic Phase Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Philadelphia Chromosome null --- T315I --- --- T315I ---