Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00996593
First received: October 8, 2009
Last updated: February 9, 2012
Last verified: February 2012
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, Non-Hodgkin
Non-Hodgkin's Lymphoma
Intervention: Biological: Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (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
Participants received radioimmunotherapy of tositumomab (TST) and Iodine I 131 TST in 2 phases: Phase 1, dosimetric dose; Phase 2, therapeutic dose. After radioimmunotherapy, participants could have entered a 10-year Long-Term Follow-Up study (Study BEX104526; NCT00240591) for continued evaluation.

Reporting Groups
  Description
TST and Iodine I 131 TST Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Participant Flow for 2 periods

Period 1:   Dosimetric and Therapeutic Treatment
    TST and Iodine I 131 TST  
STARTED     43  
COMPLETED     0  
NOT COMPLETED     43  
Lost to Follow-up                 7  
Withdrawal by Subject                 3  
Progressive Disease                 22  
Death                 1  
Enrolled in BEX104526                 6  
Did Not Receive Any Study Drug                 3  
Non-compliance                 1  

Period 2:   Long-Term Follow-Up
    TST and Iodine I 131 TST  
STARTED     9 [1]
COMPLETED     6  
NOT COMPLETED     3  
Withdrawal by Subject                 2  
Site Closed                 1  
[1] 9 of the 40 participants withdrawing from Study BEX104507 enrolled in long-term follow-up study.



  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
TST and Iodine I 131 TST Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

Baseline Measures
    TST and Iodine I 131 TST  
Number of Participants  
[units: participants]
  40  
Age [1]
[units: Years]
Mean ± Standard Deviation
  57.0  ± 11.8  
Gender [1]
[units: Participants]
 
Female     13  
Male     27  
Race/Ethnicity, Customized [1]
[units: participants]
 
White     33  
Hispanic     3  
Asian     1  
Black     3  
[1] Baseline characteristics are summarized for the Intent-to-Treat (ITT) Population, comprised of all participants who were enrolled into the study and received at least one dose of study drug.



  Outcome Measures
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1.  Primary:   Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

2.  Primary:   Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

3.  Primary:   Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

4.  Primary:   Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

5.  Primary:   Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

6.  Primary:   Duration of Response for Confirmed CR as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

7.  Primary:   Duration of Response for CR and CCR as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

8.  Primary:   Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

9.  Primary:   Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

10.  Primary:   Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

11.  Primary:   Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

12.  Primary:   Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

13.  Primary:   Progression-free Survival for Participants With or Without a Prior Response to Rituximab   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

14.  Primary:   Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

15.  Primary:   Overall Survival   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

16.  Secondary:   Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

17.  Secondary:   Number of Participants With the Indicated Type of Infection   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

18.  Secondary:   Number of Participants With an Infection for Which Anti-infectives Were Administered   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

19.  Secondary:   Number of Participants With Serious Adverse Events (SAE) Related to Study Drug   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

20.  Secondary:   Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

21.  Secondary:   Nadir Values for ANC, a Hematologic Parameter   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

22.  Secondary:   Nadir Values for Hemoglobin, a Hematologic Parameter   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

23.  Secondary:   Nadir Values for Hematologic Parameters Platelets and WBC Count   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

24.  Secondary:   Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 years ]

25.  Secondary:   Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities   [ Time Frame: Participants were evaluated until death (up to 80.2 months in Study BEX104507) or were followed in the long-term follow-up study for up to 10.5 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 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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00996593     History of Changes
Other Study ID Numbers: 104507
Study First Received: October 8, 2009
Results First Received: December 21, 2011
Last Updated: February 9, 2012
Health Authority: United States: Food and Drug Administration