Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage I, Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049036
First received: November 12, 2002
Last updated: April 28, 2014
Last verified: December 2012
Results First Received: May 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: AIDS-related Diffuse Large Cell Lymphoma
AIDS-related Immunoblastic Large Cell Lymphoma
AIDS-related Peripheral/Systemic Lymphoma
AIDS-related Small Noncleaved Cell Lymphoma
Interventions: Biological: rituximab
Drug: etoposide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Other: laboratory biomarker analysis

  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
EPOCH + Concurrent Rituximab Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
EPOCH Followed by Rituximab Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.

Participant Flow:   Overall Study
    EPOCH + Concurrent Rituximab     EPOCH Followed by Rituximab  
STARTED     51     55  
COMPLETED     51     55  
NOT COMPLETED     0     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
EPOCH + Concurrent Rituximab Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
EPOCH Followed by Rituximab Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    EPOCH + Concurrent Rituximab     EPOCH Followed by Rituximab     Total  
Number of Participants  
[units: participants]
  51     55     106  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     51     54     105  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  42.6  ± 8.4     42.6  ± 9.4     42.6  ± 8.9  
Gender  
[units: participants]
     
Female     8     7     15  
Male     43     48     91  
Region of Enrollment  
[units: participants]
     
United States     51     55     106  



  Outcome Measures

1.  Primary:   Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment   [ Time Frame: 60 days ]


  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 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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeannette Lee
Organization: AIDS Malignancy Consortium
phone: 501-526-6712
e-mail: jylee@uams.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049036     History of Changes
Other Study ID Numbers: NCI-2012-02926, NCI-2012-02926, ECOG-AMC34, CDR0000257660, AMC-034, AMC-034, U01CA070019
Study First Received: November 12, 2002
Results First Received: May 23, 2011
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration