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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

April 6, 2010
April 19, 2013
April 2010
January 2014   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01100502 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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

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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Disease, Hodgkin
  • Drug: brentuximab vedotin
    Every 21 days by IV infusion (1.8 mg/kg)
    Other Name: SGN-35
  • Drug: placebo
    Every 21 days by IV infusion
  • Experimental: 1
    brentuximab vedotin
    Intervention: Drug: brentuximab vedotin
  • Active Comparator: 2
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
329
April 2016
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Poland,   Romania,   Russian Federation,   Serbia,   Spain,   United Kingdom
 
NCT01100502
SGN35-005
Yes
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP