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Trial record 2 of 9 for:    brentuximab vedotin | Phase 3

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 19, 2019
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2010
First Posted Date  ICMJE April 9, 2010
Results First Submitted Date  ICMJE July 31, 2015
Results First Posted Date  ICMJE November 11, 2015
Last Update Posted Date March 19, 2019
Study Start Date  ICMJE April 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: April 8, 2010)
Progression-free survival [ Time Frame: Until disease progression or study closure ]
Change History Complete list of historical versions of study NCT01100502 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Disease, Hodgkin
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 5, 2012)
329
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2010)
322
Estimated Study Completion Date  ICMJE April 2020
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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  ICMJE NCT01100502
Other Study ID Numbers  ICMJE SGN35-005
2009-016947-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Millennium Pharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Julie Lisano, PharmD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date March 2019

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