This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
Name: Nilotinib, interferon-alfa
Type: DrugNilotinib in conjunction with low dose interferon alfa
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
Inclusion Criteria: - Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening - Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow - Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments - Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment - No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen Exclusion Criteria: - Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases - Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I) - Impaired cardiac function - Severe or uncontrolled medical conditions (i.e. --- T315I ---
Other protocol-defined inclusion/exclusion criteria may apply Inclusion Criteria: - Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening - Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow - Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments - Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment - No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen Exclusion Criteria: - Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases - Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I) - Impaired cardiac function - Severe or uncontrolled medical conditions (i.e. --- T315I ---