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Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577629
First Posted: December 20, 2007
Last Update Posted: May 30, 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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Duke University
Results First Submitted: March 4, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma, B-Cell
Interventions: Drug: cyclophosphamide
Drug: etoposide
Drug: rituximab
Drug: cytarabine
Drug: doxorubicin
Drug: tositumomab

  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
Subjects were recruited between September 2005 and March 2011 at Duke University Medical Center.

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
All Subjects Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar

Participant Flow for 2 periods

Period 1:   Treatment Period
    All Subjects
STARTED   39 
COMPLETED   38 
NOT COMPLETED   1 
Death                1 

Period 2:   Long Term Follow-Up
    All Subjects
STARTED   38 
COMPLETED   13 
NOT COMPLETED   25 
Death                15 
Lost to Follow-up                5 
Withdrawal by Subject                4 
Physician Decision                1 



  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 Subjects Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      25  64.1% 
>=65 years      14  35.9% 
Age, Customized 
[Units: Years]
Mean (Full Range)
 60 
 (21 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  30.8% 
Male      27  69.2% 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   1 Year Progression-free Survival Rate   [ Time Frame: 1 year ]

2.  Secondary:   Disease-free Survival   [ Time Frame: 10 years ]

3.  Secondary:   Overall Survival   [ Time Frame: 10 years ]

4.  Secondary:   Overall Response   [ Time Frame: up to 1 year ]

5.  Secondary:   Secondary Malignancies   [ Time Frame: 10 years ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Anne Beaven, MD
Organization: Duke University Medical Center
phone: 919-684-8964
e-mail: anne.beaven@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00577629     History of Changes
Other Study ID Numbers: Pro00007096
GSK-103421 ( Other Grant/Funding Number: GSK )
5762 ( Other Identifier: DUMC old IRB # )
First Submitted: December 18, 2007
First Posted: December 20, 2007
Results First Submitted: March 4, 2013
Results First Posted: April 15, 2013
Last Update Posted: May 30, 2017