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)

Seagen Inc.329 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

329

Conditions

Disease, Hodgkin

Interventions

brentuximab vedotinDRUG

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

placeboDRUG

Every 21 days by IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (87)

Outcomes

Primary Outcomes

Progression-free Survival by Independent Review

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

Time frame: Up to approximately 4 years

Secondary Outcomes

Overall Survival

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

Time frame: Up to approximately 10 years

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

Data from ClinicalTrials.gov

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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

...and 77 more locations