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A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00337987
First received: June 15, 2006
Last updated: February 9, 2015
Last verified: February 2015
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral T-Cell Lymphoma
Interventions: Drug: Ontak
Drug: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Denileukin Diftitox/CHOP Administration Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)

Participant Flow:   Overall Study
    Denileukin Diftitox/CHOP Administration  
STARTED     49  
COMPLETED     49  
NOT COMPLETED     0  



  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
Denileukin Diftitox/CHOP Administration Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)

Baseline Measures
    Denileukin Diftitox/CHOP Administration  
Number of Participants  
[units: participants]
  49  
Age  
[units: years]
Median (Full Range)
  52  
  (23 to 80)  
Gender  
[units: participants]
 
Female     26  
Male     23  



  Outcome Measures
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1.  Primary:   Number of Patients That Achieved a Complete Response or a Partial Response (PR)   [ Time Frame: After 4 years ]

2.  Primary:   Number of Patients That Achieved a Complete Response (CR)   [ Time Frame: After 4 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Francine Foss, MD
Organization: Yale University School of Medicine
phone: 203-737-5312
e-mail: francine.foss@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00337987     History of Changes
Other Study ID Numbers: 0507000369
Study First Received: June 15, 2006
Results First Received: January 28, 2015
Last Updated: February 9, 2015
Health Authority: United States: Institutional Review Board