Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

A Dose-Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (go) Given in Combination With Cytarabine and Daunorubicin in Relapsed or Refractory Patients and in Younger de Novo Patients With Acute Myeloid Leukemia (AML)

The primary objectives are a) to establish the maximum tolerated dose (MTD) of gemtuzumab ozogamicin in combination with cytarabine and daunorubicin, and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine and daunorubicin.

Inclusion Criteria:

• All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
• Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
• Phase II will only allow enrollment of younger de novo AML

Exclusion Criteria:

• AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
• De novo patients with M3 AML
• AML secondary to exposure to chemotherapy or radiation