The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
Name: Nilotinib
Description: participants will take nilotinib 400mg twice daily by mouth every morning and every evening approximately 12 hours apart. Participants will take two 200mg capsules at each dosing. Nilotinib is taken on an empty stomach with 8 ounces of water. No food is to be eaten for 2 hours prior to the nilotinib dose or for one hour following the dose.Type: Drugnilotinib
Description: Assess CCyR by bone marrow cytogenics
Measure: Rate of Complete Cytogenetic Response (CCyR) present at baseline Time: 6, 12, and 18 months after starting imatinib. FISH wil be conducted at the end of cycles 1,2,3,6,9,12 after the switch to nilotinibDescription: Measure MMR at the end of Cycles
Measure: Rate of a Major Molecular Response (MMR) after the switch in the therapy Time: 1,2,3,6,9,12 after the switch to nilotinibAllocation: Non-Randomized
Single Group Assignment
There is one SNP
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age 2. ECOG 0, 1, or 2 3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS) 4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol 5. CML-CP patients initiated on any dose of imatinib 6. Ability to provide written informed consent prior to any study related screening procedures being done Exclusion Criteria: 1. Loss of CHR or cytogenetic response 2. Prior accelerated phase or blast phase CML 3. Previously documented T315I mutation 4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. 5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib. --- T315I ---
Other protocol-defined inclusion/exclusion criteria may apply Inclusion Criteria: 1. Male or female patients ≥ 18 years of age 2. ECOG 0, 1, or 2 3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS) 4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol 5. CML-CP patients initiated on any dose of imatinib 6. Ability to provide written informed consent prior to any study related screening procedures being done Exclusion Criteria: 1. Loss of CHR or cytogenetic response 2. Prior accelerated phase or blast phase CML 3. Previously documented T315I mutation 4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. 5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib. --- T315I ---