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 12, 2016
Last verified: April 2016

April 6, 2010
April 12, 2016
April 2010
August 2014   (final data collection date for primary outcome measure)
Progression-free Survival by Independent Review [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
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
Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01100502 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Up to approximately 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • 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 ]
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 Names:
    • SGN-35
    • Adcetris
  • Drug: placebo
    Every 21 days by IV infusion
  • Experimental: Brentuximab vedotin
    brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    Intervention: Drug: brentuximab vedotin
  • Placebo Comparator: Placebo
    placebo every 3 weeks by IV infusion
    Intervention: Drug: placebo
Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. Erratum in: Lancet. 2015 Aug 8;386(9993):532.

*   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 2020
August 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, 2009-016947-20
Yes
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
April 2016

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