Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

61

Study ID:

NCT03625505

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 11 Locations for this study

See Locations Near You

David Geffen School of Medicin /ID# 200166
Los Angeles California, 90095, United States
UC San Francisco Medical Center-Parnassus /ID# 200205
San Francisco California, 94143, United States
Sylvester Comprehensive Cancer /ID# 200268
Miami Florida, 33136, United States
Northwestern Memorial Hospital /ID# 200230
Chicago Illinois, 60611, United States
Norton Cancer Institute /ID# 200623
Louisville Kentucky, 40202, United States
Johns Hopkins University /ID# 200349
Baltimore Maryland, 21287, United States
Mayo Clinic - Rochester /ID# 200346
Rochester Minnesota, 55905, United States
Hackensack Univ Med Ctr /ID# 200229
Hackensack New Jersey, 07601, United States
Weill Cornell Medical College /ID# 200109
New York New York, 10065, United States
Hosp of the Univ of Penn /ID# 200348
Philadelphia Pennsylvania, 19104, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 206686
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

61

Study ID:

NCT03625505

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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