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 Corporation
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled between January 2005 and July 2007. Patients were enrolled at academic centers in the US and Europe that had experience in treating CTCL patients

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients were required to have failed at least 1 prior systemic therapy, e.g., interferon, chemotherapy, Ontak® (denileukin diftitox), or Targretin® (bexarotene).

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.

Participant Flow:   Overall Study
    Romidepsin  
STARTED     102  
COMPLETED     37 [1]
NOT COMPLETED     65  
[1] 37 represents the number of patients who reached at least 6 months treatment



  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.
No text entered.

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  
Number of Participants  
[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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Elizabeth Faust, PhD, Vice President, Clinical Research Services
Organization: Celgene Corporation
phone: 617/583-1300
e-mail: EFaust@Celgene.com


No publications provided


Responsible Party: Jean Nichols, Ph.D., Gloucester Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00106431     History of Changes
Obsolete Identifiers: NCT00337025
Other Study ID Numbers: GPI-04-0001
Study First Received: March 24, 2005
Results First Received: March 2, 2010
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration