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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00577629
First received: December 18, 2007
Last updated: May 20, 2014
Last verified: March 2014
Results First Received: March 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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:   Overall Study
    All Subjects  
STARTED     39  
COMPLETED     38  
NOT COMPLETED     1  
Withdrawal by Subject                 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  
Number of Participants  
[units: participants]
  39  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     14  
Age, Customized  
[units: Years]
Mean ( Full Range )
  60  
  ( 21 to 80 )  
Gender  
[units: participants]
 
Female     12  
Male     27  
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:   Overall Response   [ Time Frame: up to 1 year ]

3.  Secondary:   Disease-free Survival in Patients With a Complete Response (CR or CRu)   [ Time Frame: 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Overall Survival   [ Time Frame: 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Secondary Malignancies   [ Time Frame: 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00577629     History of Changes
Other Study ID Numbers: Pro00007096, GSK-103421, 5762
Study First Received: December 18, 2007
Results First Received: March 4, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board