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Campath-1H and EPOCH to Treat Non-Hodgkin's T- and NK-Cell Lymphomas

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069238
First Posted: September 18, 2003
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wyndham Wilson, M.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: October 7, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Interventions: Biological: Alemtuzumab (Campath)
Drug: EPOCH

  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
No text entered.

Reporting Groups
  Description
Alemtuzumab 30 mg Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
Alemtuzumab 60 mg Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
Alemtuzumab 90 mg Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.

Participant Flow for 3 periods

Period 1:   Cohort 1 - Dose Level 1 (Weeks 1 - 18)
    Alemtuzumab 30 mg   Alemtuzumab 60 mg   Alemtuzumab 90 mg
STARTED   25   0   0 
COMPLETED   16   0   0 
NOT COMPLETED   9   0   0 
Toxicity                9                0                0 

Period 2:   Cohort 2 - Dose Level 2 (Weeks 1-18)
    Alemtuzumab 30 mg   Alemtuzumab 60 mg   Alemtuzumab 90 mg
STARTED   0   3   0 
COMPLETED   0   1   0 
NOT COMPLETED   0   2   0 
Toxicity                0                2                0 

Period 3:   Cohort 3 - Dose Level 3 (Weeks 1-18)
    Alemtuzumab 30 mg   Alemtuzumab 60 mg   Alemtuzumab 90 mg
STARTED   0   0   3 
COMPLETED   0   0   1 
NOT COMPLETED   0   0   2 
Toxicity                0                0                2 



  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
All Participants All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1   3.2% 
Between 18 and 65 years      27  87.1% 
>=65 years      3   9.7% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.52  (15.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      16  51.6% 
Male      15  48.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      31 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   6.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      15  48.4% 
White      14  45.2% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   31 


  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of Alemtuzumab   [ Time Frame: Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days. ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 67 months and 9 days ]

3.  Secondary:   Clinical Response   [ Time Frame: For patients with response:Restage sites of disease every (q) 3 months for the first year, then q4 months for the second year, and then q6 months for the next 3 years, and yearly thereafter. The timing for these visits may be adjusted + 2 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 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. Wyndham WIlson
Organization: National Cancer Institute
phone: 301-435-2415
e-mail: wilsonw@mail.nih.gov


Publications:

Responsible Party: Wyndham Wilson, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00069238     History of Changes
Obsolete Identifiers: NCT00072254
Other Study ID Numbers: 030304
03-C-0304
First Submitted: September 17, 2003
First Posted: September 18, 2003
Results First Submitted: October 7, 2015
Results First Posted: January 21, 2016
Last Update Posted: October 18, 2017