Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00121199
First received: July 19, 2005
Last updated: May 6, 2014
Last verified: December 2012
Results First Received: October 30, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Interventions: Biological: rituximab
Biological: bevacizumab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
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
CHOP + Rituximab + Bevacizumab Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.

Participant Flow:   Overall Study
    CHOP + Rituximab + Bevacizumab  
STARTED     73  
Eligible     64  
Eligible and Began Protocol Therapy     64  
COMPLETED     45  
NOT COMPLETED     28  
Adverse Event                 11  
Refusal Unrelated to Adverse Event                 1  
Progression/Relapse                 1  
Death                 3  
Other - Not Protocol Specified                 3  
Ineligible                 9  



  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
CHOP + Rituximab + Bevacizumab Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.

Baseline Measures
    CHOP + Rituximab + Bevacizumab  
Number of Participants  
[units: participants]
  64  
Age  
[units: years]
Median ( Full Range )
  67.6  
  ( 21.8 to 84.9 )  
Gender  
[units: participants]
 
Female     20  
Male     44  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     57  
Unknown or Not Reported     5  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     2  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     54  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Progression-free Survival at 1 Year   [ Time Frame: 0-1 year ]

2.  Primary:   Progression-free Survival at 2 Year   [ Time Frame: 0-2 years ]

3.  Secondary:   Objective Response (Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR))   [ Time Frame: After Cycle 4 (Day 64) but prior to Cycle 5 (Day 85) and after Cycle 8 (Day 181). After completion of protocol treatment, every 6 months for 2 years, then annually for a maximum of five years. ]

4.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment ]


  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: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00121199     History of Changes
Other Study ID Numbers: NCI-2012-03062, NCI-2012-03062, S0515, S0515, U10CA032102
Study First Received: July 19, 2005
Results First Received: October 30, 2012
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration