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ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas (ECHELON-2)

Primary Purpose

Anaplastic Large-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma

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

About this trial

This is an interventional treatment trial for Anaplastic Large-Cell Lymphoma focused on measuring Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, Monomethyl auristatin E, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
  • Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

  • History of another primary invasive malignancy that has not been in remission for at least 3 years
  • Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
  • History of progressive multifocal leukoencephalopathy (PML)
  • Cerebral/meningeal disease related to the underlying malignancy

Sites / Locations

  • Banner MD Anderson Cancer Center
  • City of Hope National Medical Center
  • Stanford Cancer Center
  • Shands Cancer Center / University of Florida
  • Orlando Health, Inc.
  • University of Illinois at Chicago
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • Holden Comprehensive Cancer Center / University of Iowa
  • University of Kansas Cancer Center
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Washington University School of Medicine
  • Memorial Sloan Kettering Cancer Center - Basking Ridge
  • Hackensack University Medical Center
  • Albert Einstein Cancer Center
  • Montefiore Medical Center
  • Memorial Sloan Kettering Cancer Center - Commack
  • Memorial Sloan Kettering Cancer Center
  • Columbia University Medical Center
  • Weill Cornell Medical College
  • James P. Wilmot Cancer Center / University of Rochester Medical Center
  • Jewish Hospital, The
  • Cleveland Clinic, The
  • Mercy Clinic Oncology
  • Thomas Jefferson University
  • Sarah Cannon Research Institute
  • Charles A. Sammons Cancer Center / Baylor University Medical Center
  • MD Anderson Cancer Center / University of Texas
  • University of Virginia
  • Virginia Commonwealth University Medical Center
  • Benaroya Research Institute/Virginia Mason Medical Center
  • Seattle Cancer Care Alliance / University of Washington
  • Royal Adelaide Hospital
  • Moorabbin Hospital
  • Icon Cancer Care Chermside
  • Icon Cancer Care South Brisbane
  • Icon Cancer Care Southport
  • Icon Cancer Care Wesley
  • Monash Medical Centre
  • Concord Repatriation General Hospital
  • St. Vincent's Hospital Sydney
  • St Vincent's Public Hospital Sydney - Fitzroy
  • Western Hospital
  • Austin Health
  • Calvary Mater Newcastle
  • McGill University Department of Oncology / McGill University Health Centre
  • Jewish General Hospital
  • Sunnybrook Health Sciences Centre
  • British Columbia Cancer Agency - Vancouver Centre
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
  • Fakultni Nemocnice Ostrava
  • Fakultni Nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze
  • Aarhus University Hospital
  • Rigs Hospiltalet
  • Odense University Hospital
  • Hôpital Henri Mondor
  • CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies
  • Centre Hospitalier Universitaire de Grenoble
  • Clinique Victor Hugo
  • CHRU de Lille
  • Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
  • Centre Hospitalier Universitaire Nantes-Hotel Dieu
  • Hopital Saint-Louis / Service d'Hematologie
  • Groupe Hospitalier Pitié-Salpétrière
  • Groupe Hospitalier du Haut Leveque
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
  • Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
  • Charite Universitatsmedizin Berlin
  • Charite Campus Benjamin Franklin
  • Klinikum Chemnitz gGmbH
  • Universitatsklinikum Essen
  • Krankenhaus Nordwest GmbH
  • Georg-August-Universität Göttingen
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum des Saarlandes
  • Klinik für Innere Medizin II, Friedrich-Schiller-Universität
  • Universitatsklinikum Koln
  • Klinikum der Ludwig-Maximilians-Universität München
  • Klinikum Nürnberg
  • Universitätsklinikum Ulm
  • Semmelweis Egyetem
  • Debreceni Egyetem
  • Somogy Megyei Kaposi Mór Oktató Kórház
  • Markusovszky Egyetemi Oktatokorhaz
  • Soroka Medical Center, Dept. of Oncology
  • Rambam Health Corp.
  • Hadassah Medical Center
  • Rabin Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
  • Azienda Ospedaliera Papa Giovanni XXIII
  • Instituto di Ematologia ed Oncologia Medica
  • Azienda Ospedaliera Spedali Civili di Brescia
  • Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
  • Azienda Ospedaliera Universitaria San Martino
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale Niguarda Ca' Granda
  • IRCSS Policlinico San Matteo
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
  • Istituto Clinico Humanitas-Humanitas Cancer Center
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Keimyung University Dongsan Medical Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Seoul Saint Mary's Hospital
  • Asan Medical Center
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
  • Malopolskie Centrum Medyczne S.C.
  • Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
  • Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
  • Spitalul Clinic Coltea
  • Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
  • Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
  • Hospital de la Santa Creu i Sant Paul
  • Institut Universitari Dexeus
  • Institut Català D'oncologia
  • Hospital de León
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Universitaro de Salamanca
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Chang Gung Memorial Hospital - Kaohsiung
  • China Medical University Hospital
  • National Cheng-Kung University Hospital
  • Chang Gung Memorial Hospital - Taoyuan
  • Addenbrooke's Hospital
  • University Hospitals of Leicester NHS Trust
  • Saint George's Hospital NHS Trust
  • Christie Hospital NHS Foundation Trust
  • Freeman Hospital
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CHOP

A+CHP

Arm Description

cyclophosphamide, doxorubicin, vincristine, and prednisone

brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone

Outcomes

Primary Outcome Measures

Progression-free Survival Per Independent Review Facility (IRF)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.

Secondary Outcome Measures

Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Overall Survival (OS)
The time from randomization to death due to any cause.
Objective Response Rate (ORR) Per IRF at End of Treatment
The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Incidence of Adverse Events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Incidence of Laboratory Abnormalities
Number of participants who experienced a Grade 3 or higher laboratory toxicity.

Full Information

First Posted
January 23, 2013
Last Updated
November 1, 2021
Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01777152
Brief Title
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Acronym
ECHELON-2
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2013 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Large-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, Monomethyl auristatin E, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHOP
Arm Type
Active Comparator
Arm Description
cyclophosphamide, doxorubicin, vincristine, and prednisone
Arm Title
A+CHP
Arm Type
Experimental
Arm Description
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
Adcetris; SGN-35
Intervention Description
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
Intervention Type
Drug
Intervention Name(s)
vincristine
Intervention Description
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Primary Outcome Measure Information:
Title
Progression-free Survival Per Independent Review Facility (IRF)
Description
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)
Description
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
Time Frame
Up to 60 months
Title
Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)
Description
The count of participants with CR per IRF following the completion of study treatment (at end of treatment or at the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame
Up to 8.34 months
Title
Overall Survival (OS)
Description
The time from randomization to death due to any cause.
Time Frame
Up to 90 months
Title
Objective Response Rate (ORR) Per IRF at End of Treatment
Description
The count of participants with CR or partial response (PR) per IRF following the completion of study treatment (at end of treatment or the first assessment after the last dose of study treatment and prior to long-term follow-up) according to the Revised Response Criteria for Malignant Lymphoma.
Time Frame
Up to 8.34 months
Title
Incidence of Adverse Events (AEs)
Description
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 8.28 months
Title
Incidence of Laboratory Abnormalities
Description
Number of participants who experienced a Grade 3 or higher laboratory toxicity.
Time Frame
Up to 8.28 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with newly diagnosed, CD30-positive mature T-cell lymphomas Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria: History of another primary invasive malignancy that has not been in remission for at least 3 years Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides History of progressive multifocal leukoencephalopathy (PML) Cerebral/meningeal disease related to the underlying malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Manley, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Shands Cancer Center / University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Orlando Health, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
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
Holden Comprehensive Cancer Center / University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
United States
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
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
Memorial Sloan Kettering Cancer Center - Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
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
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
James P. Wilmot Cancer Center / University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Jewish Hospital, The
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Cleveland Clinic, The
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Mercy Clinic Oncology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
United States
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
30384
Country
United States
Facility Name
Charles A. Sammons Cancer Center / 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
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Benaroya Research Institute/Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Moorabbin Hospital
City
Bentleigh East
ZIP/Postal Code
3165
Country
Australia
Facility Name
Icon Cancer Care Chermside
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Icon Cancer Care Southport
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Icon Cancer Care Wesley
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
St Vincent's Public Hospital Sydney - Fitzroy
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Western Hospital
City
Footscray
ZIP/Postal Code
3011
Country
Australia
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
McGill University Department of Oncology / McGill University Health Centre
City
Montreal
ZIP/Postal Code
H3H 2R9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Centre
City
Vancouver
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus C.
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Rigs Hospiltalet
City
Copenhagen
ZIP/Postal Code
DK 2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies
City
La Roche-sur-Yon Cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHRU de Lille
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes-Hotel Dieu
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Louis / Service d'Hematologie
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
Georg-August-Universität Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Klinik für Innere Medizin II, Friedrich-Schiller-Universität
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum der Ludwig-Maximilians-Universität München
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Nürnberg
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Soroka Medical Center, Dept. of Oncology
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Health Corp.
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49414
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Instituto di Ematologia ed Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale Niguarda Ca' Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCSS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Clinico Humanitas-Humanitas Cancer Center
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-876
Country
Korea, Republic of
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Hospital de la Santa Creu i Sant Paul
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Institut Català D'oncologia
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de León
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitaro de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Chang Gung Memorial Hospital - Kaohsiung
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Taoyuan
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Saint George's Hospital NHS Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35470385
Citation
Savage KJ, Horwitz SM, Advani R, Christensen JH, Domingo-Domenech E, Rossi G, Morschhauser F, Alpdogan O, Suh C, Tobinai K, Shustov A, Trneny M, Yuen S, Zinzani PL, Trumper L, Ilidge T, O'Connor OA, Pro B, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Iyer S. Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2. Blood Adv. 2022 Oct 11;6(19):5550-5555. doi: 10.1182/bloodadvances.2020003971.
Results Reference
derived
PubMed Identifier
30522922
Citation
Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illes A, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Huttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trumper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4. Erratum In: Lancet. 2019 Jan 19;393(10168):228.
Results Reference
derived
PubMed Identifier
25135998
Citation
Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
Results Reference
derived

Learn more about this trial

ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas

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