Leukemia Clinical Trial
Official title:
A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and
either kill them or deliver cancer-killing substances to them without harming normal cells.
Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells
more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more
cancer cells.
PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with
cyclosporine works in treating older patients with relapsed acute myeloid leukemia.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
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