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A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01100502
First received: April 6, 2010
Last updated: October 3, 2016
Last verified: October 2016
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Disease, Hodgkin
Interventions: Drug: brentuximab vedotin
Drug: placebo

  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
Apr 2010-Aug 2014

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

Participant Flow for 2 periods

Period 1:   Treatment Period
    Brentuximab Vedotin   Placebo
STARTED   165   164 
COMPLETED   78   81 
NOT COMPLETED   87   83 
Adverse Event                54                10 
Withdrawal by Subject                9                4 
Progressive Disease                24                69 

Period 2:   Long-Term Follow-up
    Brentuximab Vedotin   Placebo
STARTED   165 [1]   164 [1] 
COMPLETED   28 [2]   25 [2] 
NOT COMPLETED   137   139 
Withdrawal by Subject                10                8 
Lost to Follow-up                5                2 
Continuing in long-term follow-up                122                129 
[1] All participants were to be followed after treatment
[2] Completed 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.
Intention-to-Treat analysis set

Reporting Groups
  Description
Brentuximab Vedotin brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Placebo placebo every 3 weeks by IV infusion
Total Total of all reporting groups

Baseline Measures
   Brentuximab Vedotin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 165   164   329 
Age 
[Units: Years]
Median (Full Range)
 33 
 (18 to 71) 
 32 
 (18 to 76) 
 32 
 (18 to 76) 
Gender 
[Units: Participants]
     
Female   89   67   156 
Male   76   97   173 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   3   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   10   2   12 
White   153   156   309 
More than one race   0   0   0 
Unknown or Not Reported   0   3   3 
Region of Enrollment 
[Units: Participants]
     
Russian Federation   20   19   39 
Romania   4   6   10 
Hungary   9   11   20 
United States   67   68   135 
United Kingdom   3   3   6 
Spain   4   6   10 
Czech Republic   5   0   5 
Poland   26   28   54 
Italy   9   7   16 
France   8   5   13 
Serbia   3   6   9 
Bulgaria   7   2   9 
Germany   0   3   3 
Eastern Cooperative Oncology Group Performance Status [1] 
[Units: Participants]
     
 87   97   184 
 77   67   144 
 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
Hodgkin Lymphoma Status after end of Frontline Therapy 
[Units: Participants]
     
Refractory   99   97   196 
Relapse in less than 12 months   53   54   107 
Relapse 12 months or later with extranodal disease   13   13   26 
Best Response to Salvage Therapy pre-ASCT 
[Units: Participants]
     
Complete remission   61   62   123 
Partial remission   57   56   113 
Stable disease   47   46   93 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival by Independent Review   [ Time Frame: Up to approximately 4 years ]

2.  Secondary:   Incidence of Adverse Events or Laboratory Abnormalities   [ Time Frame: Up to 12 months ]

3.  Secondary:   Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin   [ Time Frame: Up to 12 months ]

4.  Secondary:   Overall Survival   [ Time Frame: Up to approximately 10 years ]
Results not yet reported.   Anticipated Reporting Date:   04/2021   Safety Issue:   No


  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
Patients are currently being followed for survival; final overall survival data are not available and will be reported upon study closure.


  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.


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: NCT01100502     History of Changes
Other Study ID Numbers: SGN35-005
2009-016947-20 ( EudraCT Number )
Study First Received: April 6, 2010
Results First Received: July 31, 2015
Last Updated: October 3, 2016
Health Authority: United States: Food and Drug Administration