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Clinical Trial Summary

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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03942094
Study type Interventional
Source Shenzhen Second People's Hospital
Contact
Status Recruiting
Phase Phase 3
Start date June 1, 2019
Completion date December 1, 2023

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