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)

Disease, Hodgkin Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100502
• Other study ID #: SGN35-005
• Secondary ID: 2009-016947-20
• Status: Completed
• Phase: Phase 3
• Start date: April 30, 2010
• Est. completion date: April 27, 2020

Study information

• Verified date: April 2021
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: April 27, 2020
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease, Hodgkin
• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
• placebo
Every 21 days by IV infusion

Locations

Country	Name	City	State
Bulgaria	Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno	Sofia
Bulgaria	Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania	Sofia
Czechia	Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie	Hradec Kralove
Czechia	Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie	Praha
Czechia	Vseobecni fakultni nemocnice v Prahe-I. interni klinika	Praha
France	CHU Nantes - Hopital Hotel Dieu Service Hematologie	Nantes
France	Service des Maladies du Sang / Hospital Saint Louis	Paris
France	CHU Bordeaux Hopital Haut-Levaque	Pessac
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer	Rouen
Germany	University Hospital of Cologne	Koeln
Hungary	Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly	Budapest
Hungary	Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika	Debrecen
Hungary	Medical Center of the University of Pecs, 1st Clinic for Internal Medicine	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont	Szeged
Italy	Instituto di Ematologia ed Oncologia Medica	Bologna
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Istituto Nazionale dei Tumori	Milano
Poland	Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach	Gliwice
Poland	Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego	Katowice
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi	Lodz
Poland	Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie	Lublin
Poland	Centrum Onkologii Institut im. Marii Sklodowskiej-Curie	Warsaw
Poland	Klinika Hematologii, Instytut Hematologii i Transfuzjologii	Warsaw
Poland	MTZ Clinical Research Sp. z o.o.	Warsaw
Romania	Fundeni Clinical Institute	Bucharest
Romania	Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu	Bucharest
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular	Targu Mures	Judetul Mures
Romania	Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie	Timisoara	Judetul Timis
Russian Federation	Burdenko Central Military Clinical Hospital	Moscow
Russian Federation	Federal Medical Biophysical Center n.a. A.I. Burnazyan	Moscow
Russian Federation	Gematologicheskj nauchnyj centr RAMN	Moscow
Russian Federation	Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN	Moscow
Russian Federation	Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii	Novosibirsk
Russian Federation	Respublikanskaja bol'nica im. V.A. Baranova	Petrozavodsk
Russian Federation	Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High	St. Petersburg
Russian Federation	Gorodskaya bol'nica #31	St. Petersburg
Russian Federation	Leningradskaja oblastnaja klinicheskaja bol'nica	St. Petersburg
Russian Federation	Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova	St. Petersburg
Russian Federation	St. Petersburg Pavlov State Medical University	St. Petersburg
Russian Federation	Sverdlovskaja oblastnaja klinicheskaja bol'nica #1	Yekaterinburg
Serbia	Klinicki centar Srbije, Klinika za hematologiju	Belgrad
Serbia	Vojnomedicinska akademija, Klinika za hematologiju	Belgrad
Serbia	Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju	Novi Sad
Spain	Hospital Clinic i Provincial Servicio Hematologia	Barcelona
Spain	Hospital de la Santa Creu i Sant Paul	Barcelona
Spain	Centro Oncologico MD Anderson	Madrid
Spain	Complejo Hospitalano de Navarra Servicio Hematologia	Pamplona	Navarra
Spain	Hospital Universitaro de Salamanca	Salamanca
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	St James University Hospital	Leeds
United Kingdom	Guy's Hospital Haematology Department, 4th Floor Southwark Wing	London
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Northside Hospital	Atlanta	Georgia
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	UNC Lineberger Comprehensive Cancer Center / University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago Section of Hematology/Oncology Lymphoma Program	Chicago	Illinois
United States	Cleveland Clinic, The	Cleveland	Ohio
United States	James Cancer Hospital / Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	Saint Francis Hospital	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380	Indianapolis	Indiana
United States	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University Cancer Institute	New York	New York
United States	Temple Bone Marrow Transplant Program	Philadelphia	Pennsylvania
United States	Western Pennsylvania Cancer Institute	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University / Center for Hematologic Malignancies	Portland	Oregon
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California at San Francisco	San Francisco	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Seagen Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Italy,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

References & Publications (1)

Moskowitz CH, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Gianni AM, Carella A, Osmanov D, Bachanova V, Sweetenham J, Sureda A, Huebner D, Sievers EL, Chi A, Larsen EK, Hunder NN, Walewski J; AETHERA Study Group. Brentuximab — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to approximately 4 years
Secondary	Overall Survival	Time from date of randomization to date of death due to any cause	Up to approximately 10 years
Secondary	Incidence of Adverse Events or Laboratory Abnormalities		Up to 12 months
Secondary	Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin		Up to 12 months