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
Allocation: N/A
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 ---