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)
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| ClinicalTrials.gov Identifier: NCT01100502 |
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Recruitment Status :
Completed
First Posted : April 9, 2010
Results First Posted : November 11, 2015
Last Update Posted : July 8, 2020
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Sponsor:
Seagen Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Disease, Hodgkin |
| Interventions |
Drug: brentuximab vedotin Drug: placebo |
| Enrollment | 329 |
Participant Flow
| Recruitment Details | Apr 2010-Aug 2014 |
| Pre-assignment Details |
| Arm/Group Title | Brentuximab Vedotin | Placebo |
|---|---|---|
 Arm/Group Description |
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion | placebo every 3 weeks by IV infusion |
| Period Title: Treatment Period | ||
| Started | 165 | 164 |
| Completed | 78 | 81 |
| Not Completed | 87 | 83 |
| Reason Not Completed | ||
| Adverse Event | 54 | 10 |
| Withdrawal by Subject | 9 | 4 |
| Progressive Disease | 24 | 69 |
| Period Title: Long-Term Follow-up | ||
| Started | 165 [1] | 164 [1] |
| Completed | 28 [2] | 25 [2] |
| Not Completed | 137 | 139 |
| Reason Not Completed | ||
| Withdrawal by Subject | 10 | 8 |
| Lost to Follow-up | 5 | 2 |
| Continuing in long-term follow-up | 122 | 129 |
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[1]
All participants were to be followed after treatment
[2]
Completed follow-up due to death
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Baseline Characteristics
| Arm/Group Title | Brentuximab Vedotin | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion | placebo every 3 weeks by IV infusion | Total of all reporting groups | |
| Overall Number of Baseline Participants | 165 | 164 | 329 | |
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Baseline Analysis Population Description |
Intention-to-Treat analysis set
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 165 participants | 164 participants | 329 participants | |
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33
(18 to 71)
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32
(18 to 76)
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32
(18 to 76)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 165 participants | 164 participants | 329 participants | |
| Female |
89 53.9%
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67 40.9%
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156 47.4%
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| Male |
76 46.1%
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97 59.1%
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173 52.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 165 participants | 164 participants | 329 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
2 1.2%
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3 1.8%
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5 1.5%
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|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
10 6.1%
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2 1.2%
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12 3.6%
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| White |
153 92.7%
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156 95.1%
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309 93.9%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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3 1.8%
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3 0.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 165 participants | 164 participants | 329 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 | |
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Eastern Cooperative Oncology Group Performance Status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 165 participants | 164 participants | 329 participants |
| 0 | 87 | 97 | 184 | |
| 1 | 77 | 67 | 144 | |
| 2 | 1 | 0 | 1 | |
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[1]
Measure Description: 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
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Hodgkin Lymphoma Status after end of Frontline Therapy
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 165 participants | 164 participants | 329 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 | |
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Best Response to Salvage Therapy pre-ASCT
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 165 participants | 164 participants | 329 participants |
| Complete remission | 61 | 62 | 123 | |
| Partial remission | 57 | 56 | 113 | |
| Stable disease | 47 | 46 | 93 | |
Outcome Measures
Adverse Events
Limitations and Caveats
Patients are currently being followed for survival; final overall survival data are not available and will be reported upon study closure.
More Information
Results Point of Contact
| Name/Title: | Chief Medical Officer |
| Organization: | Seattle Genetics Inc. |
| Phone: | (855)473-2436 |
| EMail: | medinfo@seagen.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Seagen Inc. |
| ClinicalTrials.gov Identifier: | NCT01100502 |
| Other Study ID Numbers: |
SGN35-005 2009-016947-20 ( EudraCT Number ) |
| First Submitted: | April 6, 2010 |
| First Posted: | April 9, 2010 |
| Results First Submitted: | July 31, 2015 |
| Results First Posted: | November 11, 2015 |
| Last Update Posted: | July 8, 2020 |