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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)

Primary Purpose

Disease, Hodgkin

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
brentuximab vedotin
placebo
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disease, Hodgkin focused on measuring Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, Monomethylauristatin E

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope National Medical Center
  • University of California at San Francisco
  • Stanford Cancer Center
  • Colorado Blood Cancer Institute
  • H. Lee Moffitt Cancer Center & Research Institute
  • Northside Hospital
  • Northwestern University
  • University of Chicago Section of Hematology/Oncology Lymphoma Program
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380
  • Johns Hopkins Medical Center
  • Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Karmanos Cancer Institute / Wayne State University
  • University of Minnesota
  • Washington University School of Medicine
  • Hackensack University Medical Center
  • New York University Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester Medical Center
  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
  • Cleveland Clinic, The
  • James Cancer Hospital / Ohio State University
  • Oregon Health and Science University / Center for Hematologic Malignancies
  • Temple Bone Marrow Transplant Program
  • Western Pennsylvania Cancer Institute
  • Saint Francis Hospital
  • Cancer Center of the Carolinas
  • Baylor University Medical Center
  • MD Anderson Cancer Center / University of Texas
  • Virginia Commonwealth University Medical Center
  • Fred Hutchinson Cancer Research Center
  • Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
  • Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
  • Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
  • Vseobecni fakultni nemocnice v Prahe-I. interni klinika
  • CHU Nantes - Hopital Hotel Dieu Service Hematologie
  • Service des Maladies du Sang / Hospital Saint Louis
  • CHU Bordeaux Hopital Haut-Levaque
  • Centre Hospitalier Lyon Sud
  • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
  • University Hospital of Cologne
  • Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
  • Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
  • Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
  • Instituto di Ematologia ed Oncologia Medica
  • Azienda Ospedaliera Universitaria San Martino
  • Istituto Nazionale dei Tumori
  • Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
  • Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach
  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
  • Szpital Uniwersytecki w Krakowie
  • Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
  • MTZ Clinical Research Sp. z o.o.
  • Klinika Hematologii, Instytut Hematologii i Transfuzjologii
  • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
  • Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie
  • Fundeni Clinical Institute
  • Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
  • Burdenko Central Military Clinical Hospital
  • Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
  • Federal Medical Biophysical Center n.a. A.I. Burnazyan
  • Gematologicheskj nauchnyj centr RAMN
  • Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
  • Respublikanskaja bol'nica im. V.A. Baranova
  • Leningradskaja oblastnaja klinicheskaja bol'nica
  • Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
  • St. Petersburg Pavlov State Medical University
  • Gorodskaya bol'nica #31
  • Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
  • Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
  • Klinicki centar Srbije, Klinika za hematologiju
  • Vojnomedicinska akademija, Klinika za hematologiju
  • Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
  • Complejo Hospitalano de Navarra Servicio Hematologia
  • Hospital de la Santa Creu i Sant Paul
  • Hospital Clinic i Provincial Servicio Hematologia
  • Centro Oncologico MD Anderson
  • Hospital Universitaro de Salamanca
  • Addenbrooke's Hospital
  • St James University Hospital
  • Guy's Hospital Haematology Department, 4th Floor Southwark Wing
  • Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brentuximab vedotin

Placebo

Arm Description

brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

placebo every 3 weeks by IV infusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
Time from date of randomization to date of death due to any cause
Incidence of Adverse Events or Laboratory Abnormalities
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin

Full Information

First Posted
April 6, 2010
Last Updated
April 22, 2021
Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01100502
Brief Title
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2010 (Actual)
Primary Completion Date
August 31, 2014 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease, Hodgkin
Keywords
Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, Monomethylauristatin E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab vedotin
Arm Type
Experimental
Arm Description
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo every 3 weeks by IV infusion
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
SGN-35, Adcetris
Intervention Description
Every 21 days by IV infusion (1.8 mg/kg)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Every 21 days by IV infusion
Primary Outcome Measure Information:
Title
Progression-free Survival by Independent Review
Description
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 Outcome Measure Information:
Title
Overall Survival
Description
Time from date of randomization to date of death due to any cause
Time Frame
Up to approximately 10 years
Title
Incidence of Adverse Events or Laboratory Abnormalities
Time Frame
Up to 12 months
Title
Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Lisano, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Section of Hematology/Oncology Lymphoma Program
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New York University Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic, The
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
James Cancer Hospital / Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University / Center for Hematologic Malignancies
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Temple Bone Marrow Transplant Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Western Pennsylvania Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center / University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie
City
Praha
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Vseobecni fakultni nemocnice v Prahe-I. interni klinika
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU Nantes - Hopital Hotel Dieu Service Hematologie
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Service des Maladies du Sang / Hospital Saint Louis
City
Paris
ZIP/Postal Code
75475 Cedex 10
Country
France
Facility Name
CHU Bordeaux Hopital Haut-Levaque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
University Hospital of Cologne
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine
City
Pecs
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Instituto di Ematologia ed Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego
City
Katowice
ZIP/Postal Code
40-032
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
City
Lublin
ZIP/Postal Code
20-950
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warsaw
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Klinika Hematologii, Instytut Hematologii i Transfuzjologii
City
Warsaw
ZIP/Postal Code
02-766
Country
Poland
Facility Name
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
City
Targu Mures
State/Province
Judetul Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie
City
Timisoara
State/Province
Judetul Timis
ZIP/Postal Code
300011
Country
Romania
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Burdenko Central Military Clinical Hospital
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Federal Medical Biophysical Center n.a. A.I. Burnazyan
City
Moscow
ZIP/Postal Code
123098
Country
Russian Federation
Facility Name
Gematologicheskj nauchnyj centr RAMN
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Respublikanskaja bol'nica im. V.A. Baranova
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Leningradskaja oblastnaja klinicheskaja bol'nica
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
Gorodskaya bol'nica #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Sverdlovskaja oblastnaja klinicheskaja bol'nica #1
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Klinicki centar Srbije, Klinika za hematologiju
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Vojnomedicinska akademija, Klinika za hematologiju
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Complejo Hospitalano de Navarra Servicio Hematologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31130
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Paul
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic i Provincial Servicio Hematologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Centro Oncologico MD Anderson
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitaro de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's Hospital Haematology Department, 4th Floor Southwark Wing
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25796459
Citation
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 vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. Epub 2015 Mar 19. Erratum In: Lancet. 2015 Aug 8;386(9993):532. Lancet. 2015 Aug 8;386(9993):532.
Results Reference
result
PubMed Identifier
30266774
Citation
Moskowitz CH, Walewski J, Nademanee A, Masszi T, Agura E, Holowiecki J, Abidi MH, Chen AI, Stiff P, Viviani S, Bachanova V, Sureda A, McClendon T, Lee C, Lisano J, Sweetenham J. Five-year PFS from the AETHERA trial of brentuximab vedotin for Hodgkin lymphoma at high risk of progression or relapse. Blood. 2018 Dec 20;132(25):2639-2642. doi: 10.1182/blood-2018-07-861641. Epub 2018 Sep 28.
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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)

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