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)

• 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: Seagen Inc.
• Collaborator: Millennium Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Seagen Inc.

Tracking Information

• First Submitted Date: April 6, 2010
• First Posted Date: April 9, 2010
• Results First Submitted Date: July 31, 2015
• Results First Posted Date: November 11, 2015
• Last Update Posted Date: May 14, 2021
• Actual Study Start Date: April 30, 2010
• Actual Primary Completion Date: August 31, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2015)

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

• Original Primary Outcome Measures (submitted: April 8, 2010): Progression-free survival [ Time Frame: Until disease progression or study closure ]

Current Secondary Outcome Measures (submitted: October 7, 2015)

• Overall Survival [ Time Frame: Up to approximately 10 years ]
  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 ]
• Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [ Time Frame: Up to 12 months ]

Original Secondary Outcome Measures (submitted: April 8, 2010)

• Overall survival [ Time Frame: Until study closure ]
• Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
• Incidence of anti-therapeutic antibodies (ATA) to SGN-35 [ Time Frame: Through 1 month following last dose ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Disease, Hodgkin

Intervention

• 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

Study Arms

• 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

Publications *

• 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. Lancet. 2015 Aug 8;386(9993):532.
• Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 5, 2012): 329
• Original Estimated Enrollment (submitted: April 8, 2010): 322
• Actual Study Completion Date: April 27, 2020
• Actual Primary Completion Date: August 31, 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01100502
• Other Study ID Numbers: SGN35-005; 2009-016947-20 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Seagen Inc.
• Original Responsible Party: Eric Sievers, MD, Seattle Genetics, Inc.
• Current Study Sponsor: Seagen Inc.
• Original Study Sponsor: Same as current
• Collaborators: Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Julie Lisano, PharmD; Seagen Inc.

• PRS Account: Seagen Inc.
• Verification Date: April 2021