Biomarker study of Quizartinib resistance mechanisms and outcomes in patients with FLT3-ITD positive relapsed or refractory acute myeloid leukemia - JSCT FLT3-AML20

Harada Mine0 个研究点目标入组 51 人开始时间: 2020年5月27日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Gaining the written informed consent to participate in this study.
•2.Age >=0 years
•3.Morphologically diagnosed with AML defined by World Health Organization criteria (2017)
•4.Relapse or refractory after prior therapy, with or without HSCT
•5. Patients who have been tested for FLT3 mutations with companion diagnosis in the past and have agreed to retest for FLT3 mutations after enrollment in this study.
•6.ECOG Performance Status(PS)0-2
•7.Women of childbearing potential and men who agreed with birth control during Quizartinib treatment period and defined period after last dose of Quizartinib (6 months in female and 3 months in male).
•Women who dont have childbearing potential are considered postmenopausal patients if they have had no menstruation for a minimum of 2 years or have undergone surgery such as hysterectomy.

•1.Prior treatment with Quizartinib
•2.History of another malignancy.
•Non-melanoma skin cancer, carcinoma in situ, or cervical intraepithelial neoplasia are eligible.
•Organ-confined prostate cancer are eligible.
•3.Acute promyelocytic leukemia
•4.Difficulties in BM aspiration during the study due to patients condition
•5.QTcF interval is >450 ms within 14 days prior to enrolment
•6.Patients with following disease
•Active hepatitis B or C
•History of positive HIV antibody test
•Prolonged QT syndrome, ventricular arrhythmia
•Other heart diseases that lead to arrhythmias
•Electrolyte abnormalities (hypokalaemia, hypomagnesemia, etc.)
•Severe liver failure(Child-Pugh category C)
•7.Females who are pregnant
•8.Females who are breastfeeding and must agree not to breastfeed during Quizartinib treatment and 5 weeks after last dose of Quizartinib.
•9.Considered inappropriate for the study by the investigator (if hormonal therapy has been begun, or if the tumor has been surgically removed or treated with definitive radiotherapy).

发起方

Harada Mine