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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT03904251
Eligibility Criteria:
Inclusion Criteria:
* Bone marrow blasts \>= 5% that develops after remission, no restriction on prior number of relapses or regimens
* Eastern Cooperative Oncology Group (ECOG) 0-2
* At least a 3-month duration of remission prior to relapse
* Participants with relapse after allogeneic transplantation are included
* Up to 1 cycle of hypomethylating agent monotherapy at time of relapse is allowed, must be discontinued at least 14 days prior to start of salvage induction
* Serum total bilirubin =\< 2.0 mg/dL, unless considered due to Gilbert?s disease or leukemia involvement
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 times the upper limit of normal, unless considered due to leukemia involvement
* Alkaline phosphatase =\< 3 times the upper limit of normal, unless considered due to leukemia involvement
* Serum creatinine =\< 2.0 mg/dL, or creatinine clearance \> 40 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR)
* Ability to give full informed consent on their own
* Females of reproductive potential (postmenopausal for less than 24 consecutive months) must have a negative pregnancy
Exclusion Criteria:
* Currently receiving targeted therapy for FLT3 (cytokine receptor tyrosine kinase class III), IDH1, or IDH2 (isocitrate dehydrogenase, 1, 2) mutations and intent to continue use; prior use of targeted therapy for such mutations is allowed, but agents should be discontinued 1 week prior to enrollment
* Acute promyelocytic leukemia
* Second malignancy that would limit survival by less than 2 years
* New York Heart Association class III or VI
* Left ventricular ejection fraction \< 50%
* History of coronary stent placement that requires mandatory continuation of dual-antiplatelet therapy
* History of Wilson?s disease or other copper handling disorders
* Hypersensitivity to cytarabine, daunorubicin, or liposomal products
* Active invasive fungal infection
* Active bacterial or viral infection manifesting as fevers or hemodynamic instability within the past 72 hours
* Lifetime cumulative daunorubicin-equivalent anthracycline dose \> 368 mg/m\^2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03904251
Study Brief:
Protocol Section:
NCT03904251