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)
This study is ongoing, but not recruiting participants.
Sponsor:
Seattle Genetics, Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01100502
First received: April 6, 2010
Last updated: April 19, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Disease, Hodgkin |
Drug: brentuximab vedotin Drug: placebo |
Phase 3 |
An investigational treatment associated with this study has been approved for sale to the public. More info ...
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Seattle Genetics, Inc.:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: Until study closure ] [ Designated as safety issue: No ]
- Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
- Incidence of anti-therapeutic antibodies (ATA) to SGN-35 [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 329 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
brentuximab vedotin
|
Drug: brentuximab vedotin
Every 21 days by IV infusion (1.8 mg/kg)
Other Name: SGN-35
|
|
Active Comparator: 2
placebo
|
Drug: placebo
Every 21 days by IV infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100502
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Hide Study LocationsLocations
| United States, California | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010-3000 | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94134 | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Colorado Blood Cancer Institute | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Northside Hospital | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago Section of Hematology/Oncology Lymphoma Program | |
| Chicago, Illinois, United States, 60637-1470 | |
| Cardinal Bernardin Cancer Center / Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380 | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Johns Hopkins Medical Center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Karmanos Cancer Institute / Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| New York University Cancer Institute | |
| New York, New York, United States, 10016 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| UNC Lineberger Comprehensive Cancer Center / University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Cleveland Clinic, The | |
| Cleveland, Ohio, United States, 44195 | |
| James Cancer Hospital / Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health and Science University / Center for Hematologic Malignancies | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Temple Bone Marrow Transplant Program | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Western Pennsylvania Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Carolina | |
| Cancer Center of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| Saint Francis Hospital | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| MD Anderson Cancer Center / University of Texas | |
| Houston, Texas, United States, 77030-4095 | |
| United States, Virginia | |
| Virginia Commonwealth University Medical Center | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Bulgaria | |
| Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno | |
| Sofia, Bulgaria, 1527 | |
| Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania | |
| Sofia, Bulgaria, 1756 | |
| Czech Republic | |
| Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie | |
| Praha, Czech Republic, 10034 | |
| Vseobecni fakultni nemocnice v Prahe-I. interni klinika | |
| Praha, Czech Republic, 128 08 | |
| France | |
| CHU Nantes - Hopital Hotel Dieu Service Hematologie | |
| Nantes, France, 44000 | |
| Service des Maladies du Sang / Hospital Saint Louis | |
| Paris, France, 75475 Cedex 10 | |
| CHU Bordeaux Hopital Haut-Levaque | |
| Pessac, France, 33600 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69310 | |
| Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer | |
| Rouen, France, 76038 | |
| Germany | |
| University Hospital of Cologne | |
| Koeln, Germany, 50924 | |
| Hungary | |
| Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly | |
| Budapest, Hungary, 1097 | |
| Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika | |
| Debrecen, Hungary, 4004 | |
| Medical Center of the University of Pecs, 1st Clinic for Internal Medicine | |
| Pecs, Hungary | |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont | |
| Szeged, Hungary, 6720 | |
| Italy | |
| Instituto di Ematologia ed Oncologia Medica | |
| Bologna, Italy, 40138 | |
| Azienda Ospedaliera Universitaria San Martino | |
| Genova, Italy, 16132 | |
| Istituto Nazionale dei Tumori | |
| Milano, Italy, 20133 | |
| Poland | |
| Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne | |
| Gdansk, Poland, 80-952 | |
| Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach | |
| Gliwice, Poland, 44-101 | |
| Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego | |
| Katowice, Poland, 40-032 | |
| Szpital Uniwersytecki w Krakowie | |
| Krakow, Poland, 31-501 | |
| Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi | |
| Lodz, Poland, 93-510 | |
| Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie | |
| Lublin, Poland, 20-950 | |
| Centrum Onkologii Institut im. Marii Sklodowskiej-Curie | |
| Warsaw, Poland, 02-781 | |
| Klinika Hematologii, Instytut Hematologii i Transfuzjologii | |
| Warsaw, Poland, 02-766 | |
| MTZ Clinical Research Sp. z o.o. | |
| Warsaw, Poland, 02-106 | |
| Romania | |
| Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular | |
| Targu Mures, judetul Mures, Romania, 540136 | |
| Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie | |
| Timisoara, judetul Timis, Romania, 300011 | |
| Fundeni Clinical Institute | |
| Bucharest, Romania, 022328 | |
| Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu | |
| Bucharest, Romania, 022328 | |
| Russian Federation | |
| Gematologicheskj nauchnyj centr RAMN | |
| Moscow, Russian Federation, 125167 | |
| Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN | |
| Moscow, Russian Federation, 115478 | |
| Federal Medical Biophysical Center n.a. A.I. Burnazyan | |
| Moscow, Russian Federation, 123098 | |
| Burdenko Central Military Clinical Hospital | |
| Moscow, Russian Federation, 105229 | |
| Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii | |
| Novosibirsk, Russian Federation, 630099 | |
| Respublikanskaja bol'nica im. V.A. Baranova | |
| Petrozavodsk, Russian Federation, 185019 | |
| St. Petersburg Pavlov State Medical University | |
| St. Petersburg, Russian Federation, 197101 | |
| Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova | |
| St. Petersburg, Russian Federation, 197022 | |
| Gorodskaya bol'nica #31 | |
| St. Petersburg, Russian Federation, 197110 | |
| Leningradskaja oblastnaja klinicheskaja bol'nica | |
| St. Petersburg, Russian Federation, 194291 | |
| Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High | |
| St. Petersburg, Russian Federation, 197341 | |
| Sverdlovskaja oblastnaja klinicheskaja bol'nica #1 | |
| Yekaterinburg, Russian Federation, 620102 | |
| Serbia | |
| Klinicki centar Srbije, Klinika za hematologiju | |
| Beograd, Serbia, 11000 | |
| Vojnomedicinska akademija, Klinika za hematologiju | |
| Beograde, Serbia, 11000 | |
| Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju | |
| Novi Sad, Serbia, 21000 | |
| Spain | |
| Complejo Hospitalano de Navarra Servicio Hematologia | |
| Pamplona, Navarra, Spain, 31130 | |
| Hospital de la Santa Creu i Sant Paul | |
| Barcelona, Spain, 08025 | |
| Hospital Clinic i Provincial Servicio Hematologia | |
| Barcelona, Spain, 08036 | |
| Centro Oncologico MD Anderson | |
| Madrid, Spain, 28033 | |
| Hospital Universitaro de Salamanca | |
| Salamanca, Spain, 37007 | |
| United Kingdom | |
| Addenbrooke`s Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| St James University Hospital | |
| Leeds, United Kingdom, LS9 7TF | |
| Guy`s Hospital Haematology Department, 4th Floor Southwark Wing | |
| London, United Kingdom, SE1 9RT | |
| Christie Hospital NHS Foundation Trust | |
| Manchester, United Kingdom, M20 4BX | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
| Study Director: | Naomi Hunder, MD | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01100502 History of Changes |
| Other Study ID Numbers: | SGN35-005 |
| Study First Received: | April 6, 2010 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Disease, Hodgkin Drug Therapy |
Hematologic Diseases Immunotherapy Lymphoma Monomethylauristatin E |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013