Chronic Myeloid Leukemia, Chronic Phase Clinical Trial
Official title:
A Phase 4 Study of Nilotinib in Korean Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase
ENESTKorea is a phase 4, multi-institutional, single-arm, open-label study investigating the efficacy and safety of nilotinib at the currently approved dose (300 mg twice daily) and its exposure-outcome relationship, in adult patients diagnosed as Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Nilotinib is a second-generation tyrosine kinase inhibitor with improved efficacy compared to
imatinib. However, there are still many patients for whom the therapeutic response is
inadequate, or toxicity is limiting the treatment. Serum concentration of nilotinib was shown
to affect time to response and progression in previous studies. Therefore, the investigators
hypothesized that the optimal plasma level of nilotinib that is sufficient to achieve
adequate clinical response while not generating major adverse events could be elucidated by
the analysis of combined clinical and pharmacokinetic data.
ENESTKorea is a phase 4, multi-institutional, single-arm, open-label study investigating the
efficacy and safety of nilotinib at the currently approved dose (300 mg twice daily), in
adult patients diagnosed as Philadelphia chromosome (Ph)-positive chronic myeloid leukemia in
chronic phase (CML-CP). Plasma samples are collected every three months, for up to 12 months,
to determine plasma nilotinib concentrations (PNCs). The primary endpoint is the cumulative
rate of molecular response 4.5 (MR4.5; BCR-ABL1IS ≤ 0.0032%) by 24 months. Secondary
endpoints include the cumulative rates of MR3 (BCR-ABLIS ≤ 0.1%) and MR4 (BCR-ABLIS ≤ 0.01%)
by 12 and 24 months; time to MR3, MR4, and MR4.5; progression-free survival (PFS); overall
survival (OS). Correlations between PNCs and clinical outcomes are also analyzed.
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