A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

January 1, 2005

Primary Completion Date

June 1, 2008

Study Completion Date

December 1, 2008

Conditions
Cutaneous T-cell Lymphoma
Interventions
DRUG

romidepsin (depsipeptide, FK228)

Study patients received romidepsin at a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.

Trial Locations (11)

19104

University of Pennsylvania Abrahamson Cancer Center, Philadelphia

37232

Vanderbilt-Ingram Cancer Center, Nashville

77030

MD Anderson Cancer Center, Houston

90095

UCLA Jonsson Cancer Center, Los Angeles

94305

Stanford Comprehensive Cancer Center, Stanford

02118

Boston Medical Center, Boston

Unknown

Research Site, Multiple Locations

Research Site, Multiple Locations

Research Site, Multiple Locations

Research Site, Multiple Locations

Research Site, Multiple Locations

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Celgene

INDUSTRY