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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.
Sponsor:
Information provided by:
Celgene
ClinicalTrials.gov Identifier:
NCT00106431
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
  Description
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
   Romidepsin 
Overall Participants Analyzed 
[Units: Participants]
 102 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   79 
>=65 years   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (11.93) 
Gender 
[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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