Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00268203
First received: December 20, 2005
Last updated: March 20, 2014
Last verified: January 2014
Results First Received: October 10, 2013  
Study Type: Interventional
Condition: Lymphoma, Non-Hodgkin
Intervention: Biological: Iodine I 131 Tositumomab Therapeutic Regimen

  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
NHL=Non-Hodgkin's Lymphoma.

Reporting Groups
  Description
Tositumomab and Iodine I-131 Tositumomab Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.

Participant Flow:   Overall Study
    Tositumomab and Iodine I-131 Tositumomab  
STARTED     765  
Completed 2 Years of Follow-up     62  
COMPLETED     118 [1]
NOT COMPLETED     647  
Lost to Follow-up                 92  
Withdrawal by Subject                 9  
Received Other NHL Therapy                 7  
Progressive Disease                 359  
Death                 84  
Reason Not Specified                 34  
Completed 2 Years of Follow-up                 62  
[1] These participants completed 10 years of follow-up.



  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
Tositumomab and Iodine I-131 Tositumomab Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by 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 (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.

Baseline Measures
    Tositumomab and Iodine I-131 Tositumomab  
Number of Participants  
[units: participants]
  765  
Age  
[units: Years]
Mean ± Standard Deviation
  58.8  ± 11.5  
Gender  
[units: Participants]
 
Female     354  
Male     411  
Race/Ethnicity, Customized [1]
[units: participants]
 
White     711  
Hispanic     19  
Asian     7  
Black     20  
Native American     1  
Portuguese     1  
Middle Eastern     1  
Iranian     1  
Indian     2  
Arab     1  
Peruvian     1  
[1] Race data were not collected; ethnicity data were collected and are presented instead.



  Outcome Measures
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1.  Primary:   Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response   [ Time Frame: From randomization until the first documented complete response or partial response (up to 161 months) ]

2.  Primary:   Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response   [ Time Frame: From randomization until the first documented complete response or partial response (up to 161 months) ]

3.  Primary:   Duration of Response for Participants With Unconfirmed Response (CR+PR)   [ Time Frame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months) ]

4.  Primary:   Duration of Response for Participants With Confirmed Response (CR+PR)   [ Time Frame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months) ]

5.  Primary:   Duration of Response (DOR) in Unconfirmed Complete Responders   [ Time Frame: From the time of the first documented unconfirmed CR until PD (up to 161 months) ]

6.  Primary:   Duration of Response (DOR) in Confirmed Complete Responders   [ Time Frame: From the time of the first documented CR until PD (up to 161 months) ]

7.  Primary:   Time to Progression or Death   [ Time Frame: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months) ]

8.  Secondary:   Time to Treatment Failure   [ Time Frame: From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months) ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00268203     History of Changes
Other Study ID Numbers: BEX104545, EAP CP-98-020
Study First Received: December 20, 2005
Results First Received: October 10, 2013
Last Updated: March 20, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Federal Office of Public Health
United States: Food and Drug Administration