Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT03625505
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03625505
Study Brief:
Protocol Section:
NCT03625505