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 not yet accepting 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
not yet accepting 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
August 8, 2018