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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT04214860
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent and ability to comply with protocol requirements.
2. Documented diagnosis of AML according to World Health Organization WHO) classification
3. Adequate organ function as defined by the following laboratory values:
1. Creatinine clearance \> 30 mL/min
2. Total serum bilirubin \< 1.5 × ULN
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 × ULN
4. Age ≥18 years
5. At least one TP53 mutation
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
7. Projected life expectancy of ≥ 12 weeks.
8. Negative serum or urine pregnancy test
9. Females of childbearing potential and males with female partners of childbearing potential must be willing to use an effective form of contraception
Exclusion Criteria:
1. Prior treatment for TP53-mutant AML (\*dependent upon treatment arm assigned).
2. Known history of HIV or active hepatitis B or active hepatitis C infection.
3. Any of the following cardiac abnormalities:
1. Myocardial infarction within six months prior to registration;
2. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction (LVEF) \< 40%;
3. A history of familial long QT syndrome;
4. Symptomatic atrial or ventricular arrhythmias
5. QTcF ≥ 470 msec, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor.
4. Concomitant malignancies for which patients are receiving active therapy
5. Known active CNS involvement from AML.
6. Malabsorption syndrome
7. Pregnancy or lactation.
8. Active uncontrolled systemic infection (viral, bacterial or fungal).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04214860
Study Brief:
Protocol Section:
NCT04214860