NCT00062075

Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

PRIMARY OBJECTIVES: 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV

Timeline

• Start date: 2003-05-01
• Primary completion: 2007-03-01
• First posted: 2003-06-06
• Last updated: 2015-12-04

Locations

2 sites across 1 country: United States