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Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490009
First Posted: June 22, 2007
Last Update Posted: March 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.
Collaborators:
Corixa Corporation
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
Results First Submitted: January 9, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: Bexxar
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Potassium Iodide (KI)

  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
Bexxar Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.

Participant Flow:   Overall Study
    Bexxar
STARTED   9 
COMPLETED   9 
NOT COMPLETED   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
Bexxar Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.

Baseline Measures
   Bexxar 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3  33.3% 
>=65 years      6  66.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   5 
Male   4 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  11.1% 
Not Hispanic or Latino      8  88.9% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1  11.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      7  77.8% 
More than one race      0   0.0% 
Unknown or Not Reported      1  11.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Response Rate   [ Time Frame: 6 years ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: 1.5 months; 3 months; 6 months; or Not Progressed ]

3.  Secondary:   Overall Survival (OS) Rate   [ Time Frame: 6 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
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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.


Results Point of Contact:  
Name/Title: Susan J Knox, MD, Associate Professor of Radiation Oncology
Organization: Stanford University Medical Center
phone: 650-725-2720
e-mail: sknox@stanford.edu



Responsible Party: Susan Knox, Stanford University
ClinicalTrials.gov Identifier: NCT00490009     History of Changes
Other Study ID Numbers: IRB-10275
LYMNHL0019 ( Other Identifier: OnCore )
30978 ( Other Identifier: Stanford SPO )
First Submitted: June 20, 2007
First Posted: June 22, 2007
Results First Submitted: January 9, 2017
Results First Posted: February 28, 2017
Last Update Posted: March 30, 2017