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Clinical Trial Summary

The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)


Clinical Trial Description

A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03625388
Study type Interventional
Source Hikma Pharmaceuticals LLC
Contact
Status Completed
Phase Phase 2
Start date November 5, 2018
Completion date July 22, 2023

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