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 : May 14, 2021
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Sponsor:
Seagen Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.
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Brief Summary:
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Disease, Hodgkin | Drug: brentuximab vedotin Drug: placebo | Phase 3 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 329 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant |
| Actual Study Start Date : | April 30, 2010 |
| Actual Primary Completion Date : | August 31, 2014 |
| Actual Study Completion Date : | April 27, 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Brentuximab vedotin
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brentuximab vedotin
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
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Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Names:
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Placebo Comparator: Placebo
placebo every 3 weeks by IV infusion
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Drug: placebo
Every 21 days by IV infusion |
Primary Outcome Measures :
- Progression-free Survival by Independent Review [ Time Frame: Up to approximately 4 years ]Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
Secondary Outcome Measures :
- Overall Survival [ Time Frame: Up to approximately 10 years ]Time from date of randomization to date of death due to any cause
- Incidence of Adverse Events or Laboratory Abnormalities [ Time Frame: Up to 12 months ]
- Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Up to 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with HL who have received ASCT in the previous 30-45 days
- Patients at high risk of residual HL post ASCT
- Histologically-confirmed HL
- ECOG of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Previous treatment with brentuximab vedotin
- Previously received an allogeneic transplant
- Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
- History of another primary malignancy that has not been in remission for at least 3 years
- Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100502
Locations
Show 87 study locations
Sponsors and Collaborators
Seagen Inc.
Millennium Pharmaceuticals, Inc.
Investigators
| Study Director: | Julie Lisano, PharmD | Seagen Inc. |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: | April 9, 2010 Key Record Dates |
| Results First Posted: | November 11, 2015 |
| Last Update Posted: | May 14, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Seagen Inc.:
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Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Disease, Hodgkin Drug Therapy |
Hematologic Diseases Immunotherapy Lymphoma Monomethylauristatin E |
Additional relevant MeSH terms:
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Brentuximab Vedotin Antineoplastic Agents, Immunological Antineoplastic Agents Immunotoxins Immunoconjugates Immunologic Factors Physiological Effects of Drugs |