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Brief Title: Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML
Official Title: A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient
Study ID: NCT04402723
Brief Summary: This phase Ⅰ study of Donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess safety and pharmacokinetics in patients with Relapsed AML.
Detailed Description: Donafenib is a multikinase inhibitor which is acting on various cellular pathways involved in the genesis of acute myeloid leukemia (AML). Donafenib is therefore a promising candidate for improvement of chemotherapy results in AML. This clinical trial evaluates the safety and pharmacokinetics of Donafenib combination with Cytarabine/Daunorubicin for AML in patients between 18 and 55 years of age.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Institute of Hematology and Blood Disease Hospital, Tianjin, Tianjin, China
Name: Jianxiang Wang, Doctor
Affiliation: Institute of Hematology and Blood Disease Hospital
Role: PRINCIPAL_INVESTIGATOR