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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)

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ClinicalTrials.gov Identifier: NCT01100502
Recruitment Status : Active, not recruiting
First Posted : April 9, 2010
Results First Posted : November 11, 2015
Last Update Posted : March 15, 2018
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

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

Access to an investigational treatment associated with this study is 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
Study Start Date : April 2010
Primary Completion Date : August 2014
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Show 87 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Julie Lisano, PharmD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01100502     History of Changes
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: March 15, 2018
Last Verified: March 2018

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Drug Therapy
Hematologic Diseases
Monomethylauristatin E

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs