Phase 2 study of quizartinib

Phase 2 open-label, single-arm study of Quizartinib (AC220) monotherapy in Japanese patients with FLT3-ITD positive refractory or relapsed acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223386

Enrollment

Registered

2016-11-21

Start date

2017-01-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia (AML)

Interventions

investigational material(s) Generic name etc : AC220 INN of investigational material : Quizartinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -AML patients in first relapse or refractory after all prior therapy. -Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood. -ECOG Performance Status(PS) of 0 to 2.

Exclusion criteria

Exclusion criteria: -Diagnosis of acute promyelocytic leukemia. -AML secondary to prior chemotherapy for other neoplasms. -Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy. -Prior treatment with a FLT3 targeted therapy. -Active infection not well controlled by antibacterial, antifungal and/or antiviral therapy.

Design outcomes

Primary

Measure	Time frame
efficacy Composite complete remission rate -Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood.	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics -Best response, response rate, overall survival, event free survival, leukemia-free survival -Safety -Pharmacokinetics -Tumor response will be assessed by the bone marrow findings, and absolute neutrophil count and platelet count in the peripheral blood. -To assess the safety according to CTCAE -To measure the concentration of quizartinib in the peripheral blood.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026