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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: April 12, 2016
Last verified: April 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  
Number of Participants  
[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]
     
0     87     97     184  
1     77     67     144  
2     1     0     1  
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  
[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
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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: April 12, 2016
Health Authority: United States: Food and Drug Administration