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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wyndham Wilson, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00069238
First received: September 17, 2003
Last updated: December 15, 2015
Last verified: December 2015
Results First Received: October 7, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Interventions: Biological: Alemtuzumab (Campath)
Drug: EPOCH

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     27  
>=65 years     3  
Age  
[units: years]
Mean (Standard Deviation)
  49.52  (15.5)  
Gender  
[units: participants]
 
Female     16  
Male     15  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     31  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     15  
White     14  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
  Show All Outcome Measures

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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
Study First Received: September 17, 2003
Results First Received: October 7, 2015
Last Updated: December 15, 2015
Health Authority: United States: Federal Government