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

Phase 2

• Conditions: Acute myeloid leukemia

• Registration Number: JPRN-jRCTs071200015
• Lead Sponsor: Harada Mine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified