Back to resultsA Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Primary Purpose
Hodgkin Lymphoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
brentuximab vedotin
doxorubicin
bleomycin
vinblastine
dacarbazine
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring Hodgkin Lymphoma, Hodgkins Lymphoma, Antibody, Monoclonal, Antibody-Drug Conjugate, Antigens, CD-30, Immunotherapy, Lymphoma, Lymphoma, Classical, ECHELON-1
Eligibility Criteria
Inclusion Criteria:
- Treatment-naïve participants with Ann Arbor Stage III or IV HL.
- Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
- Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
Exclusion Criteria:
- Nodular lymphocyte predominant Hodgkin lymphoma.
- Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
- Sensory or motor peripheral neuropathy.
- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
- Known human immunodeficiency virus (HIV) positive.
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A + AVD
ABVD
Arm Description
A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.
ABVD consists of doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.
Outcomes
Primary Outcome Measures
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.
Secondary Outcome Measures
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.
Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Number of Participants With Abnormal Clinical Laboratory Values
Event-free Survival (EFS) Per IRF
EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF.
Disease-free Survival (DFS) Per IRF
DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.
Overall Response Rate (ORR) Per IRF
ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Duration of Response (DOR) Per IRF
DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Duration of Complete Remission (DOCR) Per IRF
DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.
Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy
CR was defined as disappearance of all evidence of disease as determined by an IRF.
Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.
Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2
PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.
A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)
A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE
A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.
Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir.
Full Information
NCT ID
NCT01712490
First Posted
October 19, 2012
Last Updated
April 6, 2023
Sponsor
Takeda
Collaborators
Seagen Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01712490
Brief Title
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Official Title
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 9, 2012 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
January 13, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Seagen 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 open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
Hodgkin Lymphoma, Hodgkins Lymphoma, Antibody, Monoclonal, Antibody-Drug Conjugate, Antigens, CD-30, Immunotherapy, Lymphoma, Lymphoma, Classical, ECHELON-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A + AVD
Arm Type
Experimental
Arm Description
A+AVD consists of brentuximab vedotin (ADCETRIS®) 1.2 milligram per kilogram (mg/kg) plus doxorubicin 25 milligram per square meter (mg/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.
Arm Title
ABVD
Arm Type
Active Comparator
Arm Description
ABVD consists of doxorubicin 25 mg/m^2, bleomycin 10 units per square meter (units/m^2), vinblastine 6 mg/m^2, and dacarbazine (DTIC) 375 mg/m^2.
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
ADCETRIS®, SGN-35
Intervention Description
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
bleomycin
Intervention Description
Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
vinblastine
Intervention Description
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Other Intervention Name(s)
DTIC
Intervention Description
Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Primary Outcome Measure Information:
Title
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
Description
mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.
Time Frame
Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.
Time Frame
Baseline until death (approximately up to 4 years)
Title
Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
Description
CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.
Time Frame
Baseline up to end of randomized regimen (approximately 1 year)
Title
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time Frame
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Title
Number of Participants With Abnormal Clinical Laboratory Values
Time Frame
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Title
Event-free Survival (EFS) Per IRF
Description
EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF.
Time Frame
Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
Title
Disease-free Survival (DFS) Per IRF
Description
DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.
Time Frame
From CR until PD or death (approximately up to 4 years)
Title
Overall Response Rate (ORR) Per IRF
Description
ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time Frame
Baseline up to end of randomized regimen (approximately 1 year)
Title
Duration of Response (DOR) Per IRF
Description
DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.
Time Frame
From first documented response until PD (approximately 4 years)
Title
Duration of Complete Remission (DOCR) Per IRF
Description
DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.
Time Frame
From first documentation of CR until PD (approximately 4 years)
Title
Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy
Description
CR was defined as disappearance of all evidence of disease as determined by an IRF.
Time Frame
Baseline up to end of frontline therapy (approximately 4 years)
Title
Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
Description
CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.
Time Frame
Baseline up to end of frontline therapy (approximately 4 years)
Title
Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2
Description
PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.
Time Frame
Cycle 2 Day 25
Title
A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)
Time Frame
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Title
A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Time Frame
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Title
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
Time Frame
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Title
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE
Time Frame
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Title
A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
Description
The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.
Time Frame
Baseline up to end of treatment (approximately 1 year)
Title
Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
Description
EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir.
Time Frame
Baseline up to end of treatment (approximately 1 year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Treatment-naïve participants with Ann Arbor Stage III or IV HL.
Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
Exclusion Criteria:
Nodular lymphocyte predominant Hodgkin lymphoma.
Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
Sensory or motor peripheral neuropathy.
Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Gilbert
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Burbank
State/Province
California
Country
United States
City
Duarte
State/Province
California
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Fullerton
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Luis Obispo
State/Province
California
Country
United States
City
Santa Barbara
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Lonetree
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Lawrenceville
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Niles
State/Province
Illinois
Country
United States
City
Zion
State/Province
Illinois
Country
United States
City
Fort Wayne
State/Province
Indiana
Country
United States
City
Goshen
State/Province
Indiana
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Fairway
State/Province
Kansas
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Springfield
State/Province
Missouri
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Basking Ridge
State/Province
New Jersey
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Morristown
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Bronx
State/Province
New York
Country
United States
City
Commack
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Rockville Centre
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Bismarck
State/Province
North Dakota
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Eugene
State/Province
Oregon
Country
United States
City
Hershey
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Tyler
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Kennewick
State/Province
Washington
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Vancouver
State/Province
Washington
Country
United States
City
Yakima
State/Province
Washington
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Kingswood
State/Province
New South Wales
Country
Australia
City
St Leonards
State/Province
New South Wales
Country
Australia
City
Westmead
State/Province
New South Wales
Country
Australia
City
South Brisbane
State/Province
Queensland
Country
Australia
City
Bedford Park
State/Province
South Australia
Country
Australia
City
Hobart
State/Province
Tasmania
Country
Australia
City
East Melbourne
State/Province
Victoria
Country
Australia
City
Geelong
State/Province
Victoria
Country
Australia
City
Heidelberg
State/Province
Victoria
Country
Australia
City
Parkville
State/Province
Victoria
Country
Australia
City
Perth
State/Province
Western Australia
Country
Australia
City
Antwerpen
Country
Belgium
City
Brugge
Country
Belgium
City
Gent
Country
Belgium
City
Salvador
State/Province
Bahia
Country
Brazil
City
Curitiba
State/Province
Parana
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
City
Santo Andre
State/Province
Sao Paulo
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Sao paulo
Country
Brazil
City
Edmonton
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
City
Hradec Kralove
Country
Czechia
City
Prague
Country
Czechia
City
Praha 10
Country
Czechia
City
Aalborg
Country
Denmark
City
Aarhus C
Country
Denmark
City
Copenhagen
Country
Denmark
City
Odense C
Country
Denmark
City
Roskilde
Country
Denmark
City
Argenteuil
State/Province
Cedex
Country
France
City
La Tronche
Country
France
City
Limoges
Country
France
City
Paris
Country
France
City
Lai Chi Kok
State/Province
Kowloon
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Tuen Mun
Country
Hong Kong
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Gyor
Country
Hungary
City
Pecs
Country
Hungary
City
Szeged
Country
Hungary
City
Modena
State/Province
Emilia-Romagna
Country
Italy
City
Roma
State/Province
Lazio
Country
Italy
City
Alessandria
Country
Italy
City
Bologna
Country
Italy
City
Cagliari
Country
Italy
City
Cuneo
Country
Italy
City
Genova
Country
Italy
City
Milano
Country
Italy
City
Napoli
Country
Italy
City
Rionero In Volture
Country
Italy
City
Rome
Country
Italy
City
Rozzano
Country
Italy
City
Torrette Di Ancona
Country
Italy
City
Minami-ku
State/Province
Fukuoka-city
Country
Japan
City
Higashi-ku
State/Province
Fukuoka
Country
Japan
City
Minami-ku
State/Province
Hiroshima-city
Country
Japan
City
Showamachi
State/Province
Maebashi-city
Country
Japan
City
Chikusa-ku
State/Province
Nagoya
Country
Japan
City
Suita
State/Province
Osaka Prefecture
Country
Japan
City
Aoba-ku
State/Province
Sendai-city
Country
Japan
City
Chuo-ku
Country
Japan
City
Isehara-shi
Country
Japan
City
Koto-ku
Country
Japan
City
Goyang
State/Province
Gyeonggi
Country
Korea, Republic of
City
Hwasun-gun
State/Province
Jeollanam-do
Country
Korea, Republic of
City
Seocho-gu
State/Province
Seoul
Country
Korea, Republic of
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Jeonju
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Bergen
Country
Norway
City
Oslo
Country
Norway
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Krakow
Country
Poland
City
L0dz
Country
Poland
City
Olsztyn
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Saint-Petersburg
State/Province
Poselok Pesochny
Country
Russian Federation
City
Ufa
State/Province
Republic Of Bashkortostan
Country
Russian Federation
City
Kazan
State/Province
Republic Tatrstan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Moskva
Country
Russian Federation
City
St.Petersburg
Country
Russian Federation
City
Johannesburg
State/Province
Gauteng
Country
South Africa
City
Pretoria
State/Province
Gauteng
Country
South Africa
City
Amanzimtoti
State/Province
Kwa Zulu Natal
Country
South Africa
City
Bloemfontein
Country
South Africa
City
Cape Town
Country
South Africa
City
Badalona
Country
Spain
City
Barcelona
Country
Spain
City
Marbella
Country
Spain
City
Pamplona
Country
Spain
City
Salamanca
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Valencia
Country
Spain
City
Changhua City
Country
Taiwan
City
Chiayi County 613
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan County
Country
Taiwan
City
Ankara
Country
Turkey
City
Istanbul
Country
Turkey
City
Samsun
Country
Turkey
City
Truro
State/Province
Cornwall
Country
United Kingdom
City
Aberdeen
State/Province
Scotland
Country
United Kingdom
City
Glasgow
State/Province
Scotland
Country
United Kingdom
City
Sutton
State/Province
Surrey
Country
United Kingdom
City
Cardiff
State/Province
Wales
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
Canterbury
Country
United Kingdom
City
Exeter
Country
United Kingdom
City
Inverness
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Lincoln
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Norfolk
Country
United Kingdom
City
Northwood
Country
United Kingdom
City
Nottingham
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Romford
Country
United Kingdom
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
35830649
Citation
Ansell SM, Radford J, Connors JM, Dlugosz-Danecka M, Kim WS, Gallamini A, Ramchandren R, Friedberg JW, Advani R, Hutchings M, Evens AM, Smolewski P, Savage KJ, Bartlett NL, Eom HS, Abramson JS, Dong C, Campana F, Fenton K, Puhlmann M, Straus DJ; ECHELON-1 Study Group. Overall Survival with Brentuximab Vedotin in Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2022 Jul 28;387(4):310-320. doi: 10.1056/NEJMoa2206125. Epub 2022 Jul 13.
Results Reference
derived
PubMed Identifier
34162178
Citation
Evens AM, Connors JM, Younes A, Ansell SM, Kim WS, Radford J, Feldman T, Tuscano J, Savage KJ, Oki Y, Grigg A, Pocock C, Dlugosz-Danecka M, Fenton K, Forero-Torres A, Liu R, Jolin H, Gautam A, Gallamini A. Older patients (aged >/=60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: a detailed analysis from the phase III ECHELON-1 study. Haematologica. 2022 May 1;107(5):1086-1094. doi: 10.3324/haematol.2021.278438.
Results Reference
derived
PubMed Identifier
34048680
Citation
Straus DJ, Dlugosz-Danecka M, Connors JM, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Munoz J, Lee HJ, Kim WS, Advani R, Ansell SM, Younes A, Gallamini A, Liu R, Little M, Fenton K, Fanale M, Radford J. Brentuximab vedotin with chemotherapy for stage III or IV classical Hodgkin lymphoma (ECHELON-1): 5-year update of an international, open-label, randomised, phase 3 trial. Lancet Haematol. 2021 Jun;8(6):e410-e421. doi: 10.1016/S2352-3026(21)00102-2. Erratum In: Lancet Haematol. 2022 Feb;9(2):e91.
Results Reference
derived
PubMed Identifier
31945149
Citation
Straus DJ, Dlugosz-Danecka M, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Ramchandren R, Zinzani PL, Hutchings M, Connors JM, Radford J, Munoz J, Kim WS, Advani R, Ansell SM, Younes A, Miao H, Liu R, Fenton K, Forero-Torres A, Gallamini A. Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study. Blood. 2020 Mar 5;135(10):735-742. doi: 10.1182/blood.2019003127.
Results Reference
derived
PubMed Identifier
30617130
Citation
Ramchandren R, Advani RH, Ansell SM, Bartlett NL, Chen R, Connors JM, Feldman T, Forero-Torres A, Friedberg JW, Gopal AK, Gordon LI, Kuruvilla J, Savage KJ, Younes A, Engley G, Manley TJ, Fenton K, Straus DJ. Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma. Clin Cancer Res. 2019 Mar 15;25(6):1718-1726. doi: 10.1158/1078-0432.CCR-18-2435. Epub 2019 Jan 7.
Results Reference
derived
PubMed Identifier
29224502
Citation
Connors JM, Jurczak W, Straus DJ, Ansell SM, Kim WS, Gallamini A, Younes A, Alekseev S, Illes A, Picardi M, Lech-Maranda E, Oki Y, Feldman T, Smolewski P, Savage KJ, Bartlett NL, Walewski J, Chen R, Ramchandren R, Zinzani PL, Cunningham D, Rosta A, Josephson NC, Song E, Sachs J, Liu R, Jolin HA, Huebner D, Radford J; ECHELON-1 Study Group. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma. N Engl J Med. 2018 Jan 25;378(4):331-344. doi: 10.1056/NEJMoa1708984. Epub 2017 Dec 10. Erratum In: N Engl J Med. 2018 Mar 1;378(9):878.
Results Reference
derived
PubMed Identifier
24239220
Citation
Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.
Results Reference
derived
Learn more about this trial
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
We'll reach out to this number within 24 hrs