Retreatment of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00938041
First received: July 9, 2009
Last updated: February 27, 2014
Last verified: July 2013
Results First Received: February 27, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma, Non-Hodgkin
Intervention: Biological: Tositumomab and Iodine I 131 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
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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
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.

Participant Flow:   Overall Study
    Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab  
STARTED     32  
COMPLETED     5  
NOT COMPLETED     27  
Lost to Follow-up                 6  
Received Alternative Therapy                 1  
Progressive Disease                 5  
Death                 12  
Adrenal Insufficiency                 3  



  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
Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.

Baseline Measures
    Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab  
Number of Participants  
[units: participants]
  32  
Age  
[units: Years]
Mean ± Standard Deviation
  58.1  ± 12.5  
Gender  
[units: Participants]
 
Female     13  
Male     19  
Race/Ethnicity, Customized  
[units: Participants]
 
White     32  



  Outcome Measures
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1.  Primary:   Number of Participants With Complete Response and Confirmed Complete Response   [ Time Frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) ]

2.  Primary:   Duration of Response for All Confirmed Responders (CR + CCR + PR)   [ Time Frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) ]

3.  Primary:   Progression-free Survival   [ Time Frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) ]

4.  Primary:   Time to Treatment Failure   [ Time Frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) ]

5.  Primary:   Overall Survival   [ Time Frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) ]

6.  Primary:   Number of Participants With Any Serious Adverse Event (SAE) and Adverse Event (AE)   [ Time Frame: Every 6 months until disease progression, death, or for 2 years following the dosimetric dose, whichever occurred first (average of 80.2 months) ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00938041     History of Changes
Other Study ID Numbers: 393229/010
Study First Received: July 9, 2009
Results First Received: February 27, 2014
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration