Bisantrene Combination for Resistant AML

Inclusion Criteria

• •1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations.
• •2. Age 18 -65 (inclusive) years
• •3. Diagnosis of AML by World Health Organization (WHO) classification (WHO, 2016) and have received at least one line of therapy prior to enrollment into this study.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.0
• •5. Life expectancy ≥ 3 months.
• •6. Adequate organ function as evidenced by serum total bilirubin ≤ 2.0 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤4 × the upper limit of normal (ULN), serum albumin \>2.8 g/dL, serum creatinine ≤2 mg/dL.
• •7. Cardiac ejection fraction ≥50%, assessed by 2-Dimensional echocardiogram.
• •8. Pulmonary function ≥50% assessed by diffusing capacity for carbon monoxide (DLCO), and any clinically significant decrease in DLCO must not be caused by infection.
• •9. Negative for serum markers for HIV, Hepatitis -B, -C, and HTLV-1
• •10. Clinically significant non-hematologic toxicity after prior chemotherapy has recovered to Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
• •11. Females must be surgically or biologically sterile or postmenopausal (amenorrhoeic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before study entry, and must agree to use an adequate method of contraception, i.e. barrier method, during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception, i.e. barrier method, during the study until 30 days after the last treatment.