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

History of Changes

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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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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 ]

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6. Secondary:

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

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7. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor can review results at least 60 days prior to the date of submission for publication or public disclosure; sponsor will complete review within review period and will have authority to require institution/PI to delete confidential information other than the results.

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
No text entered.

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

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