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A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination with Gilteritinib in Subjects with Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial Details

The purposes of this study are to see if the study drugs venetoclax and gilteritinib can be safely and effectively combined for the treatment of patients with acute myeloid leukemia (AML) that has returned after prior treatment or has failed to respond to prior treatment and identify potential biomarkers. 

Venetoclax has been approved by the United States (US) Food and Drug Administration (FDA) and other health authorities to treat specific types of blood cancers. Gilteritinib is approved for the treatment of FLT3 mutation positive relapsed or refractory AML and is currently approved by Pharmaceutical Medical Devices Agency (PMDA) in Japan as well as by the US FDA. However, the FDA or other regulatory agencies have not yet found Gilteritinib safe and/or effective to treat patients when combined with venetoclax. Therefore, the use of these study drugs in combination is investigational (experimental) for the purposes of this study. 

This is the first study of venetoclax in combination with gilteritinib. Venetoclax in combination with gilteritinib may or may not work better than either drug alone.

Key Eligibility: 
  • Open to men and women above the age of 18 who have been diagnosed with Relapsed/Refractory Acute Myeloid Leukemia
  • The participant should have failed at least 1 line of prior therapy
  • Participant does not have a diagnosis of acute promyelocytic leukemia (APL)
  • Participant does not have a diagnosis of BCR-ABL-positive leukemia

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


Victoria Mendez

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group