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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 11 Locations for this study
Los Angeles California, 90095, United States
San Francisco California, 94143, United States
Miami Florida, 33136, United States
Chicago Illinois, 60611, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21287, United States
Rochester Minnesota, 55905, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.