Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies

Inclusion Criteria

• •Patients must have one of the following pathologically confirmed diagnoses:
• •AML in relapse,
• •AML refractory to at least 2 courses of standard induction chemotherapy or one course of high-dose cytarabine-containing induction chemotherapy,
• •CML in accelerated phase or myeloid blast crisis that has progressed after treatment with imatinib and a second generation tyrosine kinase inhibitor (e.g., dasatinib or nilotinib)
• •RAEB with International Prognostic Scoring System (IPSS) score ≥ 2.5, or - CMMOL with IPSS score ≥ 2.5 refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine) refractory to or relapsed after a hypomethylating agent (e.g., azacitidine or decitabine).
• •Greater than 25% of bone marrow blasts must be CD33 positive.
• •Patients must have a life expectancy of at least 6 weeks and a Karnofsky performance status of ≥ 60%.
• •Adequate renal function as demonstrated by a serum creatinine ≤ 1.5 mg/dl, a creatinine clearance \> 60 ml/min, and \< 1 gram urinary protein/24 hours.
• •Adequate hepatic function as demonstrated by a bilirubin ≤ 1.5 mg/dl (unless attributable to leukemia or Gilbert's disease) and alkaline phosphatase and AST ≤ 2.5 times the upper limit of normal.