A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
- Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the
complete remission rate, in older patients with relapsed acute myeloid leukemia.
- Determine the toxicity and pharmacokinetics of this regimen in these patients.
- Correlate clinical response with laboratory studies of drug susceptibility in patients
treated with this regimen.
OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17.
Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab
ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Efficacy in terms of complete remission rate
Stephen H. Petersdorf, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|