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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Disease, Hodgkin

In brief

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).

Key facts

Study ID

NCT01100502

Run by

Seagen Inc.

People needed

329

Starts

2010-04-30

Expected to finish

2020-04-27

Last updated by the study team

2021-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• New York University Cancer Institute — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• UNC Lineberger Comprehensive Cancer Center / University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic, The — Cleveland, Ohio, United States
• James Cancer Hospital / Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University / Center for Hematologic Malignancies — Portland, Oregon, United States
• Temple Bone Marrow Transplant Program — Philadelphia, Pennsylvania, United States
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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