Acute myeloid leukemia
Conditions
Interventions
After enrollment, 5mL of bone marrow will be collected for biomarker measurement, and administration of quizartinib will be initiated. Quizartinib will be administrated once dially, 1cycle is defined
Sponsors
Harada Mine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quizartinib resistance mechanism types and percentage of resistance mutations | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy of quizartinib Evaluation of safety of quizartinib | — |
Contacts
Public ContactMine Harada
Karatsu Higashimatsuura Medical Center
Outcome results
None listed