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

This study has been completed.
Information provided by:
Celgene Identifier:
First received: March 24, 2005
Last updated: March 14, 2011
Last verified: March 2011
Results First Received: March 2, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cutaneous T-cell Lymphoma
Intervention: Drug: romidepsin (depsipeptide, FK228)

  Participant Flow

  Baseline Characteristics
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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
Number of Participants  
[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
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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
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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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