A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)

Subject was diagnosed as acute promyelocytic leukemia.

Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).

Subject has AML secondary to prior chemotherapy for other neoplasms (except for myelodysplastic syndrome).

Subject has clinically active central nervous system leukemia.

Subject has uncontrolled or significant cardiovascular disease, including:

* A myocardial infarction within 12 months

* Uncontrolled angina within 6 months

* History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes) or any history of arrhythmia

* Uncontrolled hypertension

Subject has baseline left ventricular ejection fraction that is ≥ 45%.

Subject has mean triplicate Fridericia-corrected QT interval (QTcF) \> 450 ms at Screening based on central reading.

Subject has congenital or acquired Long QT Syndrome at screening.

Subject has hypokalemia and/or hypomagnesemia at screening.

Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of the need for treatment.

Subject has clinically significant coagulation abnormality unless secondary to AML.

Subject is receiving or plans to receive concomitant chemotherapy or immunotherapy.

Subject has had major surgery within 4 weeks prior to the first study dose.

Subject has radiation therapy within 4 weeks prior to the first study dose.

Subject requires treatment with concomitant drugs that are strong inducers of Cytochrome P450 (CYP3A).

Subject has known pulmonary disease with diffusion capacity of lung for carbon monoxide ≤ 65%, forced expiratory volume in the first second (FEV1) ≤ 65%, dyspnea at rest or requiring oxygen or any pleural neoplasm.

Subject with systemic fungal, bacterial, viral or other uncontrolled infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. Subject needs to be off pressors and have negative blood cultures for 48 hours.

Subject has not recovered from any prior therapy related toxicities.

Subject is known to have human immunodeficiency virus infection.

Subject has active hepatitis B or C or other active hepatic disorder.

Subject has previously been treated with gilteritinib, quizartinib or crenolanib (will only apply to subjects enrolled in the phase 2 portion of the study).

Subject has active clinically significant graft-versus-host disease (GVHD) or is on treatment with systemic corticosteroids for GVHD.

Subject has relapsed after allogeneic hematopoietic stem cell transplant (HCST).

Subject has an active autoimmune disorder that makes the subject unsuitable for study treatment or participation.

Subject has any condition that makes the subject unsuitable for study participation.

What this study is about