Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients

Inclusion Criteria

• •1. Untreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents or hypomethylating agents for this diagnosis. Patients with other prior cancer diagnoses are allowed as long as they have no measurable disease, are not undergoing active therapy, and have a life expectancy of ≥ 4 months.
• •2. Patients age ≥60 years who:
• •1. Are unwilling to receive intensive (e.g. 7+3) chemotherapy, or
• •2. Have poor-risk prognostic factors defined as antecedent hematologic disorder, prior chemotherapy or XRT, abnormal karyotype other than t(8;21), inv16, or t(16;16), any karyotype with FLT3-ITD, or presenting WBC\>100K, or
• •3. Have significant comorbidities, that in the judgment of the investigator makes the subject unsuitable for standard dose induction chemotherapy (e.g. anthracycline and infusional cytarabine given as 7+3), or;
• •4. Any patient age ≥ 70 years.
• •3. Blast count ≥20%
• •4. Greater than 25% of blasts must be CD33 positive.
• •5. Adequate renal and hepatic function
• •6. ECOG ≤ 3
• •1. Untreated AML, including patients with an antecedent hematologic disorder or secondary disease. Patients with prior MDS may have received therapy with immunomodulatory agents for this diagnosis.
• •2. Patients age ≥60 years who:
• •1. Patients ≥60 years unfit to receive intensive (e.g., 7+3) chemotherapy who have:
• •* Congestive heart failure or documented cardiomyopathy with an EF ≤50%, provided that EF ≥35% or,
• •* Documented pulmonary disease with DLCO ≤65% or FEV1 ≤65%, provided that patients do not require more than 2 L of oxygen per minute or,
• •* Documented liver disease with marked elevation of transaminases \>3 x ULN or,
• •* Serum creatinine \>1.2 mg/dL
• •2. Have significant comorbidities, that in the judgment of the investigator makes the subject unsuitable for standard dose induction chemotherapy (e.g., anthracycline and infusional cytarabine given as 7+3); or
• •3. Any patient age ≥ 75 years.
• •3. Blast count ≥ 20% (WHO criteria)
• •4. Greater than 25% of blasts must be CD33 positive.
• •5. Have a circulating blast count of less than 200/mm3 (control with hydroxyurea or similar agent is allowed);
• •6. Creatinine \< 2.0 mg/dl
• •7. Estimated creatinine clearance ≥ 50ml/min
• •8. Bilirubin ≤ 2.0 mg/dl; AST and ALT \< 5.0 times the ULN
• •9. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2