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

Non-Hodgkin Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777152
• Other study ID #: SGN35-014
• Secondary ID: 2012-002751-42
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2013
• Est. completion date: October 2, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: October 2, 2020
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
• doxorubicin
50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
• prednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
• vincristine
1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
• cyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Moorabbin Hospital	Bentleigh East
Australia	Icon Cancer Care Chermside	Chermside
Australia	Icon Cancer Care South Brisbane	Chermside
Australia	Icon Cancer Care Southport	Chermside
Australia	Icon Cancer Care Wesley	Chermside
Australia	Monash Medical Centre	Clayton
Australia	Concord Repatriation General Hospital	Concord
Australia	St. Vincent's Hospital Sydney	Darlinghurst
Australia	St Vincent's Public Hospital Sydney - Fitzroy	Fitzroy
Australia	Western Hospital	Footscray
Australia	Austin Health	Heidelberg
Australia	Calvary Mater Newcastle	Waratah
Canada	Jewish General Hospital	Montreal
Canada	McGill University Department of Oncology / McGill University Health Centre	Montreal
Canada	Sunnybrook Health Sciences Centre	Toronto
Canada	British Columbia Cancer Agency - Vancouver Centre	Vancouver
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie	Hradec Kralove
Czechia	Fakultni Nemocnice Ostrava	Ostrava - Poruba
Czechia	Fakultni Nemocnice Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Denmark	Aarhus University Hospital	Aarhus C.
Denmark	Rigs Hospiltalet	Copenhagen
Denmark	Odense University Hospital	Odense C
France	Hôpital Henri Mondor	Créteil
France	CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies	La Roche-sur-Yon Cedex 9
France	Centre Hospitalier Universitaire de Grenoble	La Tronche
France	Clinique Victor Hugo	Le Mans
France	CHRU de Lille	Lille cedex
France	Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren	Limoges Cedex
France	Centre Hospitalier Universitaire Nantes-Hotel Dieu	Nantes cedex 1
France	Groupe Hospitalier Pitié-Salpétrière	Paris
France	Hopital Saint-Louis / Service d'Hematologie	Paris Cedex 10
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 Hospitalier Universitaire de Rennes, Hopital Pontchaillou	Rennes Cedex 9
France	Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer	Rouen
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitatsklinikum Essen	Essen
Germany	Krankenhaus Nordwest GmbH	Frankfurt am Main
Germany	Georg-August-Universität Göttingen	Göttingen
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Klinik für Innere Medizin II, Friedrich-Schiller-Universität	Jena
Germany	Universitatsklinikum Koln	Köln
Germany	Klinikum der Ludwig-Maximilians-Universität München	München
Germany	Klinikum Nürnberg	Nürnberg
Germany	Universitätsklinikum Ulm	Ulm
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem	Debrecen
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
Israel	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	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria	Alessandria
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Instituto di Ematologia ed Oncologia Medica	Bologna
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino	Catania
Italy	Azienda Ospedaliera Universitaria San Martino	Genova
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Ospedale Niguarda Ca' Granda	Milano
Italy	IRCSS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera Ospedali Riuniti Marche Nord	Pesaro
Italy	Università degli Studi di Roma "La Sapienza, Policlinico Umberto I	Roma
Italy	Istituto Clinico Humanitas-Humanitas Cancer Center	Rozzano
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Poland	Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza	Brzozow
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich	Chorzów
Poland	Malopolskie Centrum Medyczne S.C.	Krakow
Poland	Centrum Onkologii Institut im. Marii Sklodowskiej-Curie	Warsaw
Romania	Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu	Bucharest
Romania	Spitalul Clinic Coltea	Bucuresti
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
Spain	Hospital de la Santa Creu i Sant Paul	Barcelona
Spain	Institut Universitari Dexeus	Barcelona
Spain	Institut Català D'oncologia	L'Hospitalet de Llobregat
Spain	Hospital de León	León
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda
Spain	Hospital Universitaro de Salamanca	Salamanca
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Taiwan	Chang Gung Memorial Hospital - Kaohsiung	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng-Kung University Hospital	Tainan
Taiwan	Chang Gung Memorial Hospital - Taoyuan	Taoyuan
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Saint George's Hospital NHS Trust	London
United Kingdom	Christie Hospital NHS Foundation Trust	Manchester
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United States	Memorial Sloan Kettering Cancer Center - Basking Ridge	Basking Ridge	New Jersey
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Albert Einstein Cancer Center	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Jewish Hospital, The	Cincinnati	Ohio
United States	Cleveland Clinic, The	Cleveland	Ohio
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	City of Hope National Medical Center	Duarte	California
United States	Shands Cancer Center / University of Florida	Gainesville	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	Holden Comprehensive Cancer Center / University of Iowa	Iowa City	Iowa
United States	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Mercy Clinic Oncology	Oklahoma City	Oklahoma
United States	Orlando Health, Inc.	Orlando	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	James P. Wilmot Cancer Center / University of Rochester Medical Center	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Benaroya Research Institute/Virginia Mason Medical Center	Seattle	Washington
United States	Seattle Cancer Care Alliance / University of Washington	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Seagen Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Romania,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 60 months
Secondary	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.	Up to 60 months
Secondary	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.	Up to 8.34 months
Secondary	Overall Survival (OS)	The time from randomization to death due to any cause.	Up to 90 months
Secondary	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.	Up to 8.34 months
Secondary	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.	Up to 8.28 months
Secondary	Incidence of Laboratory Abnormalities	Number of participants who experienced a Grade 3 or higher laboratory toxicity.	Up to 8.28 months