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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Novartis Investigative Site
Leipzig, Germany
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
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
Event-free survival
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
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