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Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed AIDS-Related B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00389818
First received: October 18, 2006
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
Results First Received: May 29, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: filgrastim
Biological: pegfilgrastim
Biological: rituximab
Biological: sargramostim
Drug: cyclophosphamide
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Other: immunohistochemistry staining method
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
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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
DR-COP Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.

Participant Flow:   Overall Study
    DR-COP  
STARTED     43  
COMPLETED     40  
NOT COMPLETED     3  



  Baseline Characteristics
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Reporting Groups
  Description
DR-COP Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.

Baseline Measures
    DR-COP  
Number of Participants  
[units: participants]
 		  40  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     39  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  44.4  ± 8.3  
Gender  
[units: participants]
 		 
Female     10  
Male     30  
Region of Enrollment  
[units: participants]
 		 
United States     40  



  Outcome Measures

1.  Primary:   Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .   [ Time Frame: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation ]
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2.  Primary:   Duration of Response   [ Time Frame: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Primary:   Median Survival Time   [ Time Frame: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Rate of Bacterial, Fungal, and Opportunistic Infections   [ Time Frame: After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Relationship Between MDR-1 Expression and Response to Treatment   [ Time Frame: Baseline ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue   [ Time Frame: Baseline, after cycles 4 and 6, 1 month after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time   [ Time Frame: After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Mortality and Cause of Death   [ Time Frame: At any time through the third year after treatment discontinuation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Event-free Survival at 1 Year   [ Time Frame: 1 year post-treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Ronald Mitsuyasu, MD
Organization: AMC
phone: 310-557-1803
e-mail: rmitsuya@mednet.ucla.edu


No publications provided by AIDS Malignancy Clinical Trials Consortium

Publications automatically indexed to this study:


Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00389818     History of Changes
Other Study ID Numbers: CDR0000507634, U01CA070019, AMC-047
Study First Received: October 18, 2006
Results First Received: May 29, 2012
Last Updated: June 28, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government