Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) (NICOLI)
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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).
An Open Label, Nonrandomized, Single-center, Phase I Trial of Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) With Nilotinib in Combination With Low Dose Interferon-alpha (IFN) - NICOLI Study -
Study Start Date
Primary Completion Date
Study Completion Date
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Number of Clinically significant adverse events or abnormal laboratory values (dose-limiting toxicities) unrelated to disease progression, intercurrent illness, or concomitant medications on the combination treatment [ Time Frame: 12 months ]
Secondary Outcome Measures
Rate of major cytogenetic response (MCyR) at 6 and 12 months [ Time Frame: 12 months ]
Rate of complete cytogenetic response (CCyR) at 6 and 12 months [ Time Frame: 12 months ]
Rate of major molecular response (MMR) at 12 months [ Time Frame: 12 months ]
Safety profile of nilotinib in combination with interferon alfa, i.e. the number of dose limiting toxicities (DLT) for each interferon alfa dose level [ Time Frame: 12 months ]
Progression-free survival (PFS) [ Time Frame: 12 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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. uncontrolled diabetes, active or uncontrolled infection).
Other protocol-defined inclusion/exclusion criteria may apply