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

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ClinicalTrials.gov Identifier: NCT00106431
Recruitment Status : Completed
First Posted : March 25, 2005
Results First Posted : April 23, 2010
Last Update Posted : March 16, 2011
Information provided by:

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cutaneous T-cell Lymphoma
Intervention: Drug: romidepsin (depsipeptide, FK228)

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Romidepsin Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   79 
>=65 years   23 
[Units: Years]
Mean (Standard Deviation)
 57.0  (11.93) 
[Units: Participants]
Female   40 
Male   62 
Region of Enrollment 
[Units: Participants]
France   5 
United States   20 
Poland   24 
Russian Federation   17 
Germany   6 
United Kingdom   20 
Georgia   3 
Ukraine   7 
Eastern Cooperative Oncology Group (ECOG) Performance status 
[Units: Participants]
0, Fully active, able to carry on all pre-disease   53 
1, Restricted in physically strenuous activity but   49 
2, Ambulatory and capable of all selfcare but unab   0 

  Outcome Measures

1.  Primary:   The Percent of Patients (Pts) With Objective Disease Response   [ Time Frame: 6 months ]

2.  Secondary:   Duration of Objective Disease Response   [ Time Frame: Up to 10 months; median duration of follow up was 5.1 months ]

3.  Secondary:   Time to Objective Disease Response   [ Time Frame: Up to 10 months ]

4.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 10 months; median duration of follow up was 6.1 months ]

5.  Secondary:   Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.   [ Time Frame: Up to 10 months ]

6.  Secondary:   Duration of Objective Disease Control (ODC)   [ Time Frame: Up to 10 months; median duration of follow up was 6.0 months ]

7.  Secondary:   Percent of Pts With Objective Disease Control   [ Time Frame: Up to 10 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information