Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Promyelocytic Leukemia (M3) Recurrent Adult Acute Myeloid Leukemia||Drug: romidepsin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML|
- Response rate (complete and partial) [ Time Frame: Up to 7 years ]
- Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 7 years ]
|Study Start Date:||May 2003|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062075
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Olatoyosi Odenike||University of Chicago Comprehensive Cancer Center|