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
- Conditions
- T-Cell LymphomaAnaplastic Large-Cell LymphomaNon-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT01777152
- Lead Sponsor
- Seagen Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHOP vincristine cyclophosphamide, doxorubicin, vincristine, and prednisone CHOP doxorubicin cyclophosphamide, doxorubicin, vincristine, and prednisone CHOP prednisone cyclophosphamide, doxorubicin, vincristine, and prednisone CHOP cyclophosphamide cyclophosphamide, doxorubicin, vincristine, and prednisone A+CHP doxorubicin brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone A+CHP cyclophosphamide brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone A+CHP brentuximab vedotin brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone A+CHP prednisone brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
- Primary Outcome Measures
Name Time Method Progression-free Survival Per Independent Review Facility (IRF) Up to 60 months 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
Name Time Method Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL) Up to 60 months 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) Up to 8.34 months 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) Up to 90 months The time from randomization to death due to any cause.
Objective Response Rate (ORR) Per IRF at End of Treatment Up to 8.34 months 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) Up to 8.28 months 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 Up to 8.28 months Number of participants who experienced a Grade 3 or higher laboratory toxicity.
Trial Locations
- Locations (144)
Weill Cornell Medical College
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center - Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Benaroya Research Institute/Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Icon Cancer Care Southport
🇦🇺Chermside, Australia
Icon Cancer Care Wesley
🇦🇺Chermside, Australia
St Vincent's Public Hospital Sydney - Fitzroy
🇦🇺Fitzroy, Australia
Jewish General Hospital
🇨🇦Montreal, Canada
Calvary Mater Newcastle
🇦🇺Waratah, Australia
British Columbia Cancer Agency - Vancouver Centre
🇨🇦Vancouver, Canada
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Fakultni Nemocnice Ostrava
🇨🇿Ostrava - Poruba, Czechia
Fakultni Nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies
🇫🇷La Roche-sur-Yon Cedex 9, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren
🇫🇷Limoges Cedex, France
CHRU de Lille
🇫🇷Lille cedex, France
Hopital Saint-Louis / Service d'Hematologie
🇫🇷Paris Cedex 10, France
Centre Hospitalier Universitaire Nantes-Hotel Dieu
🇫🇷Nantes cedex 1, France
Groupe Hospitalier Pitié-Salpétrière
🇫🇷Paris, France
Groupe Hospitalier du Haut Leveque
🇫🇷Pessac, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite Cedex, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers Cedex, France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer
🇫🇷Rouen, France
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou
🇫🇷Rennes Cedex 9, France
Charite Campus Benjamin Franklin
🇩🇪Berlin, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Krankenhaus Nordwest GmbH
🇩🇪Frankfurt am Main, Germany
Georg-August-Universität Göttingen
🇩🇪Göttingen, Germany
Klinik für Innere Medizin II, Friedrich-Schiller-Universität
🇩🇪Jena, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitatsklinikum Koln
🇩🇪Köln, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg/Saar, Germany
Klinikum der Ludwig-Maximilians-Universität München
🇩🇪München, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Somogy Megyei Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Hungary
Debreceni Egyetem
🇭🇺Debrecen, Hungary
Markusovszky Egyetemi Oktatokorhaz
🇭🇺Szombathely, Hungary
Soroka Medical Center, Dept. of Oncology
🇮🇱Beer Sheva, Israel
Rambam Health Corp.
🇮🇱Haifa, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
🇮🇹Alessandria, Italy
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Instituto di Ematologia ed Oncologia Medica
🇮🇹Bologna, Italy
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
🇮🇹Catania, Italy
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Aarhus University Hospital
🇩🇰Aarhus C., Denmark
Rigs Hospiltalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense C, Denmark
Hôpital Henri Mondor
🇫🇷Créteil, France
McGill University Department of Oncology / McGill University Health Centre
🇨🇦Montreal, Canada
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Shands Cancer Center / University of Florida
🇺🇸Gainesville, Florida, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Holden Comprehensive Cancer Center / University of Iowa
🇺🇸Iowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center - Commack
🇺🇸Commack, New York, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Canada
Albert Einstein Cancer Center
🇺🇸Bronx, New York, United States
Moorabbin Hospital
🇦🇺Bentleigh East, Australia
Icon Cancer Care South Brisbane
🇦🇺Chermside, Australia
Monash Medical Centre
🇦🇺Clayton, Australia
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, Australia
Austin Health
🇦🇺Heidelberg, Australia
Western Hospital
🇦🇺Footscray, Australia
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Istituto Clinico Humanitas-Humanitas Cancer Center
🇮🇹Rozzano, Italy
Centre Hospitalier Universitaire de Grenoble
🇫🇷La Tronche, France
Universitatsklinikum Essen
🇩🇪Essen, Germany
Ospedale Niguarda Ca' Granda
🇮🇹Milano, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Università degli Studi di Roma "La Sapienza, Policlinico Umberto I
🇮🇹Roma, Italy
IRCSS Policlinico San Matteo
🇮🇹Pavia, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chang Gung Memorial Hospital - Kaohsiung
🇨🇳Kaohsiung, Taiwan
National Cheng-Kung University Hospital
🇨🇳Tainan, Taiwan
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹Verona, Italy
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Saint George's Hospital NHS Trust
🇬🇧London, United Kingdom
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Institut Català D'oncologia
🇪🇸L'Hospitalet de Llobregat, Spain
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
🇵🇱Brzozow, Poland
Malopolskie Centrum Medyczne S.C.
🇵🇱Krakow, Poland
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu
🇷🇴Bucharest, Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular
🇷🇴Targu Mures, Romania
Hospital de León
🇪🇸León, Spain
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie
🇵🇱Warsaw, Poland
Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
🇵🇱Chorzów, Poland
Spitalul Clinic Coltea
🇷🇴Bucuresti, Romania
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
China Medical University Hospital
🇨🇳Taichung, Taiwan
Institut Universitari Dexeus
🇪🇸Barcelona, Spain
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital de la Santa Creu i Sant Paul
🇪🇸Barcelona, Spain
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Chang Gung Memorial Hospital - Taoyuan
🇨🇳Taoyuan, Taiwan
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Icon Cancer Care Chermside
🇦🇺Chermside, Australia
Concord Repatriation General Hospital
🇦🇺Concord, Australia
James P. Wilmot Cancer Center / University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Hospital Universitaro de Salamanca
🇪🇸Salamanca, Spain
Cleveland Clinic, The
🇺🇸Cleveland, Ohio, United States
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Jewish Hospital, The
🇺🇸Cincinnati, Ohio, United States
Mercy Clinic Oncology
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Orlando Health, Inc.
🇺🇸Orlando, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States