Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia

PRIMARY OBJECTIVES:

I. To study safety and efficacy single agent Gemtuzumab Ozogamicin (Mylotarg®) as induction
therapy for patients with Acute Myeloid Leukemia (AML) who have relapsed after standard
treatments or who are not candidates for standard consolidation treatment after Daunorubicin
and cytosine arabinoside.

SECONDARY OBJECTIVES:

I. To correlate morbidity and mortality with the use of gemtuzumab (gemtuzumab ozogamicin)
to specific subtypes of leukemia.

II. To correlate gemtuzumab response to degree of cluster of differentiation (CD) 33
positivity.

III. To correlate FMS-Related Tyrosine Kinase 3 (FLT 3)/nucleophosmin (NPM) status and CD 33
positivity to gemtuzumab response.

IV. To document incidence of sinusoidal obstruction syndrome with the use of gemtuzumab.

OUTLINE:

Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15.
Treatment continues for 28 days in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed up monthly for 1 year.