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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 19, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Disease, Hodgkin
 Drug: brentuximab vedotin
Drug: placebo
 Phase 3

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Until study closure ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of anti-therapeutic antibodies (ATA) to SGN-35 [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Enrollment: 329
Study Start Date: April 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
brentuximab vedotin
 Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Name: SGN-35
Active Comparator: 2
placebo
 Drug: placebo
Every 21 days by IV infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100502

  Show 87 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01100502     History of Changes
Other Study ID Numbers: SGN35-005
Study First Received: April 6, 2010
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013