A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed / Refractory Acute Myeloid Leukemia
Trial Status: Active
A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R / R) acute myeloid leukemia (AML) who have failed to respond to, and / or have relapsed or progressed after at least 1 prior therapy.
- Should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016).
- Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
- Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Should have adequate hematologic, kidney and liver function as described in the protocol.
- For participants enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol.
- Has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
- Has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol.
- Has active central nervous system leukemia.
- Has a history of chronic New York Heart Association (NYHA) class IV heart failure.
- Has a corrected QT interval of > 450 ms.
- Has a chronic respiratory disease that requires continuous oxygen use.
UCLA / Jonsson Comprehensive Cancer Center
Contact: Vladimir Kustanovich
UCSF Medical Center-Mount Zion
Contact: UCSF Clinical Trials
University of Miami Miller School of Medicine-Sylvester Cancer Center
Johns Hopkins University / Sidney Kimmel Cancer Center
Mayo Clinic in Rochester
Hackensack University Medical Center
University of Pennsylvania / Abramson Cancer Center
M D Anderson Cancer Center
Trial Phase Phase I
Trial Type Treatment
- Primary ID M16-802
- Secondary IDs NCI-2018-03780
- Clinicaltrials.gov ID NCT03625505