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Completed

NCT Number: NCT01100502

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 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).

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Key information

Conditions

Disease, Hodgkin Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brentuximab Vedotin

Drug

Every 21 days by IV infusion (1.8 mg/kg)

Other names: SGN-35, Adcetris

Placebo

Drug

Every 21 days by IV infusion

Primary outcomes

  1. 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

Secondary outcomes

  1. Overall Survival

    Time frame: Up to approximately 10 years

    Time from date of randomization to date of death due to any cause

  2. Incidence of Adverse Events or Laboratory Abnormalities

    Time frame: Up to 12 months

  3. Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2020
First posted
Apr 9, 2010
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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