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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)

NCT01100502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2021-05-14

Study results available
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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).

Conditions

  • Disease, Hodgkin

Interventions

DRUG

brentuximab vedotin

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

DRUG

placebo

Every 21 days by IV infusion

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Julie Lisano, PharmD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-08-31
Completion
2020-04-27
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100502 on ClinicalTrials.gov