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:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT02682732
Eligibility Criteria:
Inclusion Criteria:
* New diagnosis of AML according to the WHO (World Health Organization) criteria
Exclusion Criteria:
* Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease.
* Acute promyelocytic leukemia (APL).
* ECOG (Eastern Cooperative Oncology Group) performance status of 3 or more
* Inadequate renal function (i.e., estimated GFR (glomerular filtration rate) \< 60 mL/min/1.73m2).
* Inadequate hepatic function (i.e., serum bilirubin \> 1.5×ULN; AST (aspartate aminotransferase), ALT (alanine aminotransferase) and ALP (alkaline phosphatase) \> 2.5×ULN)
* Presence of uncontrolled systemic fungal, bacterial, viral or other infections (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Having any other severe concurrent disease or serious organ dysfunction that may place the patient at undue risk to receive induction therapy.
* Pregnancy or lactating female.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02682732
Study Brief:
Protocol Section:
NCT02682732