Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00947856
First received: July 24, 2009
Last updated: November 17, 2015
Last verified: May 2014
Results First Received: March 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Intervention: Drug: brentuximab vedotin

  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
Jul 2009 - Mar 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BV Extension Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
BV Retreatment Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)

Participant Flow for 2 periods

Period 1:   Treatment Period
    BV Extension   BV Retreatment
STARTED   78   32 [1] 
COMPLETED   0   0 [2] 
NOT COMPLETED   78   32 
Progressive Disease                33                12 
Adverse Event                15                9 
Physician Decision                14                6 
Study Stopped by Sponsor                4                4 
Withdrawal by Subject                12                1 
[1] Two patients in extension arm re-enrolled in retreatment arm and are represented in both arms
[2] Patients treated until disease progression, unacceptable toxicity or study closure

Period 2:   Follow-up Period
    BV Extension   BV Retreatment
STARTED   78   32 [1] 
COMPLETED   27   9 [2] 
NOT COMPLETED   51   23 
Study Stopped by Sponsor                40                20 
Re-enrolled for Retreatment                2                3 
Lost to Follow-up                7                0 
Patient unavailable for site visits                1                0 
Withdrawal by Subject                1                0 
[1] All participants were followed after treatment; thus, number started will not match number completed
[2] Completed survival follow-up due to death



  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.
All participants who received treatment

Reporting Groups
  Description
BV Extension Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
BV Retreatment Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
Total Total of all reporting groups

Baseline Measures
   BV Extension   BV Retreatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 78   32   110 
Age, Customized 
[Units: Years]
Median (Full Range)
 32 
 (15 to 78) 
 37 
 (16 to 72) 
 33.5 
 (15 to 78) 
Gender 
[Units: Participants]
     
Female   35   17   52 
Male   43   15   58 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   0   3 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   7   4   11 
White   66   27   93 
More than one race   0   0   0 
Unknown or Not Reported   1   1   2 
Region of Enrollment 
[Units: Participants]
     
France   0   3   3 
United States   78   29   107 
Eastern Cooperative Oncology Group Performance Status [1] 
[Units: Participants]
     
 47   12   59 
 30   18   48 
 0   2   2 
3-5   0   0   0 
Missing   1   0   1 
[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
Disease diagnosis 
[Units: Participants]
     
Hodgkin lymphoma (HL)   68   21   89 
Systemic anaplastic large cell lymphoma (ALCL)   8   8   16 
Other   2   3   5 


  Outcome Measures
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1.  Primary:   Objective Response Rate by Investigator   [ Time Frame: Up to approximately 38 months ]

2.  Primary:   Adverse Events by Severity, Seriousness, and Relationship to Treatment   [ Time Frame: up to 39 months ]

3.  Primary:   Laboratory Abnormalities >/= Grade 3   [ Time Frame: Up to 39 months ]

4.  Secondary:   Duration of Objective Response by Kaplan-Meier Analysis   [ Time Frame: Up to 38 months ]

5.  Secondary:   Progression-free Survival by Kaplan-Meier Analysis   [ Time Frame: Up to approximately 29 months ]

6.  Secondary:   Overall Survival   [ Time Frame: Up to approximately 41 months ]

7.  Secondary:   Incidence of Antitherapeutic Antibodies   [ Time Frame: Up to 39 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
No text entered.


  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: Chief Medical Officer
Organization: Seattle Genetics, Inc.
phone: 855-473-2436
e-mail: medinfo@seagen.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00947856     History of Changes
Other Study ID Numbers: SGN35-006
2010-019932-11 ( EudraCT Number )
Study First Received: July 24, 2009
Results First Received: March 21, 2014
Last Updated: November 17, 2015
Health Authority: United States: Food and Drug Administration