for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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.

Official Title

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


Acute Myeloid Leukemia (AML) Cancer Relapsed or Refractory AML Pharmacokinetics venetoclax gilteritinib Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Dose Escalation Venetoclax + Gilteritinib Dose Expansion Venetoclax + Gilteritinib


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.


  • UC San Francisco Medical Center-Parnassus /ID# 200205
    San Francisco California 94143-2202 United States
  • David Geffen School of Medicin /ID# 200166
    Los Angeles California 90095 United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 1
Study Type
Last Updated