Nilotinib for First-line Newly Diagnosed CML-CP Patients

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    Shenzhen Second People's Hospital
Updated on 16 February 2022


This is a phase IIIb, multi-centre, single-arm, open-label, prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) in China. Nilotinib 300 mg BID will be provided in this study. The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR4.5 will be measured at this time point. Secondary endpoints include the complete hematologic response(CHR) and the rates of major molecular reactions (MMR) by 3, 6, 9,12,18 and 24 months; event free survival (EFS); overall survival (OS).

Condition Chronic Myeloid Leukemia, Chronic Phase, Nilotinib
Treatment Nilotinib
Clinical Study IdentifierNCT03942094
SponsorShenzhen Second People's Hospital
Last Modified on16 February 2022


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