Safety and Efficacy of Gemtuzumab Ozogamicin (Mylotarg®) as for Treatment of Patients With CD33-Positive Acute Myeloid Leukemia (AML)
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.
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
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.
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
After completion of study treatment, patients are followed up monthly for 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of serious adverse events
95% confidence interval will be calculated. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Approximately 1 year
Leslie Ellis, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|