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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01100502
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : November 11, 2015
Last Update Posted : May 14, 2021
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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 Design
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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


Arms and Interventions
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Arm Intervention/treatment
Experimental: Brentuximab vedotin
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
 Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Names:
  • SGN-35
  • Adcetris
Placebo Comparator: Placebo
placebo every 3 weeks by IV infusion
 Drug: placebo
Every 21 days by IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Overall Survival [ Time Frame: Up to approximately 10 years ]
    Time from date of randomization to date of death due to any cause

  2. Incidence of Adverse Events or Laboratory Abnormalities [ Time Frame: Up to 12 months ]
  3. Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Up to 12 months ]

Eligibility Criteria
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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
Contacts and Locations
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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
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Sponsors and Collaborators
Seagen Inc.
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Julie Lisano, PharmD Seagen Inc.
More Information
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Publications of Results:

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

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
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