A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML
I. Determine the complete and partial response rate in patients with relapsed or refractory
acute myeloid leukemia treated with FR901228 (depsipeptide).
II. Determine the toxicity of this drug in these patients. III. Correlate clinical response
with specific cytogenetic abnormalities in patients treated with this drug.
OUTLINE: Patients are stratified according to the presence of a specific chromosomal
abnormality (t[8;21] vs inv 16 vs t[15;17] vs absence of these chromosomal abnormalities).
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete and partial)
Up to 7 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|