A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
Trial Parameters
Brief Summary
This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML
Eligibility Criteria
Inclusion Criteria: * 1.Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial included subjects who were ≥60 years old or between 18 and 59 years old (including 18 and 59 years old) and could not tolerate strong chemotherapy. 2.It can be primary AML or AML secondary to MDS, and has not been treated; the extension phase requires the subject to be positive for the FLT3-ITD mutation. 3.The ECOG score according to the requirements of different groups is as follows: Cohort 1: 0\~1 points; Cohort 2: Age ≥60 years old: 0\~2 points; Age 18\~59 years old (including 18 and 59 years old): 0\~3 points. 4.Expected survival time ≥ 12 weeks. 5. Subjects must have adequate organ function. 6.subjects voluntarily participated in the study, and signed a written informed consent form by themselves or their guardians. Exclusion Criteria: * 1.Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation,