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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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 & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Approved
Contact: Vladimir Kustanovich
Phone: 310-206-5756
Email: VKustanovich@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M16-802
Secondary IDs NCI-2018-03780
Clinicaltrials.gov ID NCT03625505