- Refractory or relapsed (ie, bone marrow blasts >5%) CD33‑positive AML.
- Age >=12 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Initial peripheral white blood cells (WBC) counts >=30,000/mL; patients with a higher
WBC count should undergo cytoreduction.
- Adequate renal/hepatic functions
- Patients with prior treatment with gemtuzumab ozogamicin (GO).
- Patients with prior history of VOD/SOS.
- Prior HSCT is not allowed, if it was conducted within 2 months prior to study
enrollment.
- Patients with known active central nervous system (CNS) leukemia.
- Uncontrolled or active infectious status.
- Uncontrolled cardiac dysrhythmias of NCI CTCAE Grade 2, uncontrolled atrial
fibrillation of any grade.
- Sero?positivity to human immunodeficieny virus (HIV).
- Active hepatitis B or hepatitis C infection
- Chemotherapy, radiotherapy, or other anti?cancer therapy (except hydroxyurea as
cytoreduction) within 2 weeks prior to enrollment in the study.
- Major surgery within 4 weeks prior to enrollment.
- QTc interval >470 milliseconds (msec) using the Fridericia (QTcF), family or personal
history of long or short QT syndrome, Brugada syndrome or known history of QTc
prolongation, or Torsade de Pointes (TdP).
- The use of medications known to predispose to Torsades de Pointes within 2 weeks prior
to enrollment
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemtuzumab ozogamicin (GO).