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)

Phase 3

Completed

• Conditions: Disease, Hodgkin
• Interventions: Drug: placebo; Drug: brentuximab vedotin

• Registration Number: NCT01100502
• Lead Sponsor: Seagen Inc.

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 available

Study Timeline

• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Study Start: 2010-04-30
• Primary Completion: 2014-08-31
• Results First Submitted: 2015-07-31
• Results First Submitted QC: 2015-10-07
• Results First Posted: 2015-11-11
• Study Completion: 2020-04-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo every 3 weeks by IV infusion
Brentuximab vedotin	brentuximab vedotin	brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Primary Outcome Measures

Name	Time	Method
Progression-free Survival by Independent Review	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 Outcome Measures

Name	Time	Method
Overall Survival	Up to approximately 10 years	Time from date of randomization to date of death due to any cause
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin	Up to 12 months
Incidence of Adverse Events or Laboratory Abnormalities	Up to 12 months

Trial Locations

Locations (87)

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Chicago Section of Hematology/Oncology Lymphoma Program; 🇺🇸 Chicago, Illinois, United States

Cardinal Bernardin Cancer Center / Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380; 🇺🇸 Indianapolis, Indiana, United States

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