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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT03625505

Run by

AbbVie

People needed

61

Starts

2018-10-18

Expected to finish

2021-08-31

Last updated by the study team

2021-09-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• David Geffen School of Medicin /ID# 200166 — Los Angeles, California, United States
• UC San Francisco Medical Center-Parnassus /ID# 200205 — San Francisco, California, United States
• Sylvester Comprehensive Cancer /ID# 200268 — Miami, Florida, United States
• Northwestern Memorial Hospital /ID# 200230 — Chicago, Illinois, United States
• Norton Cancer Institute /ID# 200623 — Louisville, Kentucky, United States
• Johns Hopkins University /ID# 200349 — Baltimore, Maryland, United States
• Mayo Clinic - Rochester /ID# 200346 — Rochester, Minnesota, United States
• Hackensack Univ Med Ctr /ID# 200229 — Hackensack, New Jersey, United States
• Weill Cornell Medical College /ID# 200109 — New York, New York, United States
• Hosp of the Univ of Penn /ID# 200348 — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center at Texas Medical Center /ID# 206686 — Houston, Texas, United States

Full record on ClinicalTrials.gov

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