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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT03226418
Eligibility Criteria:
Inclusion criteria:
* New diagnosis of de novo, secondary or treatment-related acute myeloid leukemia (AML), other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML, or high-grade treatment-related myeloid neoplasm
* 60 years of age or older
* Karnofsky Performance Status ≥60%
* Able and willingly give signed informed consent
Exclusion criteria:
* Acute promyelocytic leukemia (APL). Participants with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected APL, who later turn out not to have APL, are eligible.
* Relapsed or refractory acute myeloid leukemia (AML) requiring salvage therapy
* Prior exposure to decitabine or azacitidine (exclusion criterion for use of decitabine or azacitidine)
* Participants requiring urgent initiation of chemotherapy for leukemia-related emergencies such as leukostasis or disseminated intravascular coagulopathy Participants will not be excluded solely based on current or prior use of debulking agent (e.g., hydroxyurea or cyclophosphamide). Prior or current use of leukapheresis will be allowed.
* Uncontrolled serious infection at enrollment. Infections are considered controlled if appropriate therapy has been instituted and, at enrollment, participants do not have signs of infection progression (e.g., hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection). Persistent fever without other signs or symptoms will not be interpreted as progressing infection.
* Uncontrolled clinically significant arrhythmia, myocardial ischemia or congestive heart failure within the past 2 weeks, that is considered a contraindication for initiation of chemotherapy by the treating physician
* Ejection fraction \< 45% will be an exclusion criterion for intensive chemotherapy. These participants may receive low intensity therapy.
* Clinically significant kidney (e.g., glomerular filtration rate (GFR) ≤ 45ml/minute or creatinine of ≥2 mg/dl) or liver dysfunction \[e.g., aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and/or bilirubin ≥2 times upper limit of normal (ULN)\] at enrollment that may prevent safe use of chemotherapy. These participants may be allowed to receive low-intensity chemotherapy. Participants with elevated bilirubin secondary to Gilbert syndrome will not be excluded.
* Any other condition that may not allow safe use of chemotherapy based on clinical judgment of treating oncologist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03226418
Study Brief:
Protocol Section:
NCT03226418