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Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Gulley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00007345
First received: December 16, 2000
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: January 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Cutaneous T Cell Lymphoma
Peripheral T Cell Lymphoma
Intervention: Drug: Romidepsin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.

Reporting Groups
  Description
Peripheral T-cell Lymphoma (PTCL) Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
Cutaneous T-cell Lymphoma (CTCL) Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.

Participant Flow:   Overall Study
    Peripheral T-cell Lymphoma (PTCL)   Cutaneous T-cell Lymphoma (CTCL)
STARTED   47   84 
COMPLETED   45   73 
NOT COMPLETED   2   11 
Refused further treatment                0                7 
Switched to alternative treatment                0                3 
Intercurrent illness                1                0 
Death on study                1                1 



  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.
Although 7 cohorts were written in the protocol, the cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.

Reporting Groups
  Description
Peripheral T-cell Lymphoma (PTCL) Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
Cutaneous T-cell Lymphoma (CTCL) Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
Total Total of all reporting groups

Baseline Measures
   Peripheral T-cell Lymphoma (PTCL)   Cutaneous T-cell Lymphoma (CTCL)   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   84   131 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31  66.0%      57  67.9%      88  67.2% 
>=65 years      16  34.0%      27  32.1%      43  32.8% 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.97  (12.56)   57.85  (13.08)   58.25  (12.86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      22  46.8%      27  32.1%      49  37.4% 
Male      25  53.2%      57  67.9%      82  62.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   2.1%      4   4.8%      5   3.8% 
Not Hispanic or Latino      46  97.9%      80  95.2%      126  96.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      3   6.4%      0   0.0%      3   2.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   8.5%      17  20.2%      21  16.0% 
White      40  85.1%      65  77.4%      105  80.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2   2.4%      2   1.5% 
Region of Enrollment 
[Units: Participants]
     
United States   39   55   94 
Australia   8   29   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a Response   [ Time Frame: up to 56.5 days ]

2.  Primary:   Duration of Response (DOR)   [ Time Frame: up to 127 months ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 147 months and 5 days ]

4.  Secondary:   Median Number of Cycles of Depsipeptide Administered   [ Time Frame: 83 cycles (i.e., each cycle is 21 days) ]

5.  Secondary:   Time to Progression   [ Time Frame: Until disease progression, or 30 days following off study date ]

6.  Secondary:   Fold Change in Histone Acetylation   [ Time Frame: 4 hours, 24 hours, and 48 hours after Romidepsin ]

7.  Secondary:   Multidrug Resistance Protein 1 (MDR1) or ATP-binding Cassette Sub-family B Member 1 (ABCB1) Gene Expression   [ Time Frame: 4 hours, 24 hours, and 48 hours after Romidepsin ]


  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
7 cohorts were consolidated for submission to the Food and Drug Administration (FDA) into the peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) groups, thus they are presented in this format.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Kieron Dunleavy
Organization: National Cancer Institute
phone: 301-435-1007
e-mail: DunleavK@mail.nih.gov


Publications of Results:
Other Publications:


Responsible Party: James Gulley, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00007345     History of Changes
Obsolete Identifiers: NCT00020436
Other Study ID Numbers: 010049
01-C-0049
Study First Received: December 16, 2000
Results First Received: January 14, 2016
Last Updated: April 13, 2017