A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

a study on Acute Myeloid Leukemia Leukemia

Summary

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

Description

Summary

A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in subjects 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

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016).
  • Subject should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy).
  • Subject should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Subject should have adequate hematologic, kidney and liver function as described in the protocol.
  • For subjects 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...

  • Subject has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia.
  • Subject has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol.
  • Subject has active central nervous system leukemia.
  • Subject has a history of chronic New York Heart Association (NYHA) class IV heart failure.
  • Subject has a corrected QT interval of > 450 ms.
  • Subject has a chronic respiratory disease that requires continuous oxygen use.

Locations

  • UC San Francisco Medical Center-Parnassus /ID# 200205 accepting new patients
    San Francisco California 94143-2202 United States
  • David Geffen School of Medicin /ID# 200166 not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT03625505
Phase
Phase 1
Study Type
Interventional
Last Updated