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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT03484520
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria:
* Known central nervous system leukemia
* Severe chronic obstructive pulmonary disease (COPD) with hypoxemia
* History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment.
* Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy.
* History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.
* Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03484520
Study Brief:
Protocol Section:
NCT03484520