A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00848926
First received: February 18, 2009
Last updated: December 20, 2013
Last verified: December 2013
Results First Received: September 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Disease, Hodgkin
Intervention: Drug: brentuximab vedotin

  Participant Flow


  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
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Baseline Measures
    Brentuximab Vedotin  
Number of Participants  
[units: participants]
  102  
Age, Customized  
[units: years]
Median ( Full Range )
  31.0  
  ( 15 to 77 )  
Gender  
[units: participants]
 
Female     54  
Male     48  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     7  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     89  
More than one race     0  
Unknown or Not Reported     1  
Eastern Cooperative Oncology Group Performance Status [1]
[units: participants]
 
0     42  
1     60  
2-5     0  
[1]

0 = Normal activity

  1. = Symptoms but ambulatory
  2. = In bed <50% of the time
  3. = In bed >50% of the time
  4. = 100% bedridden
  5. = Dead



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate by Independent Review Group   [ Time Frame: up to 12 months ]

2.  Secondary:   Complete Remission Rate by Independent Review Group   [ Time Frame: up to 12 months ]

3.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: up to 23.5 months ]

4.  Secondary:   Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis   [ Time Frame: up to 23.5 months ]

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: up to 23.5 months ]

6.  Secondary:   Overall Survival   [ Time Frame: up to 23.5 months ]

7.  Secondary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment   [ Time Frame: up to 12 months ]

8.  Secondary:   Hematology Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]

9.  Secondary:   Chemistry Laboratory Abnormalities >/= Grade 3   [ Time Frame: up to 12 months ]

10.  Secondary:   Area Under the Curve   [ Time Frame: 3 weeks ]

11.  Secondary:   Maximum Serum Concentration   [ Time Frame: 3 weeks ]

12.  Secondary:   Time of Maximum Serum Concentration   [ Time Frame: 3 weeks ]

13.  Other Pre-specified:   B Symptom Resolution   [ Time Frame: up to 12 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
Maximum duration of follow-up was 23.5 months; 69 participants remained in survival follow-up at the time of the efficacy analyses.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com


Publications of Results:

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00848926     History of Changes
Other Study ID Numbers: SG035-0003, 2008-006034-10
Study First Received: February 18, 2009
Results First Received: September 15, 2011
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration