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

JRCT ID: jRCTs071200015

Registered date:27/05/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute myeloid leukemia
• Date of first enrollment: 10/07/2020
• Target sample size: 51
• Study type: Interventional
• Intervention(s): 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 as 28 days. Quizartinib administration is defined as up to 12 cycles in study treatment. Dose and administration should be in accordance with the package insert.

Outcome(s)

• Primary Outcome: Quizartinib resistance mechanism types and percentage of resistance mutations

Secondary Outcome

Evaluation of the efficacy of quizartinib
Evaluation of safety of quizartinib

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Harada Mine
• Source(s) of Monetary Support: Daiichi Sankyo Company Limited