Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01712490
Registration number
NCT01712490
Ethics application status
Date submitted
19/10/2012
Date registered
23/10/2012
Titles & IDs
Public title
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma
Query!
Scientific title
A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Query!
Secondary ID [1]
0
0
2011-005450-60
Query!
Secondary ID [2]
0
0
C25003
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hodgkin Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Hodgkin's
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - brentuximab vedotin
Treatment: Drugs - doxorubicin
Treatment: Drugs - bleomycin
Treatment: Drugs - vinblastine
Treatment: Drugs - dacarbazine
Experimental: A + AVD - 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.
Active comparator: ABVD - 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.
Treatment: Drugs: brentuximab vedotin
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
Treatment: Drugs: doxorubicin
Doxorubicin: 25 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Treatment: Drugs: bleomycin
Bleomycin: 10 units/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Treatment: Drugs: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Treatment: Drugs: dacarbazine
Dacarbazine (DTIC): 375 mg/m\^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline until death (approximately up to 4 years)
Query!
Secondary outcome [2]
0
0
Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline up to end of randomized regimen (approximately 1 year)
Query!
Secondary outcome [3]
0
0
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Query!
Secondary outcome [4]
0
0
Number of Participants With Abnormal Clinical Laboratory Values
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Query!
Secondary outcome [5]
0
0
Event-free Survival (EFS) Per IRF
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
Query!
Secondary outcome [6]
0
0
Disease-free Survival (DFS) Per IRF
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
From CR until PD or death (approximately up to 4 years)
Query!
Secondary outcome [7]
0
0
Overall Response Rate (ORR) Per IRF
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Baseline up to end of randomized regimen (approximately 1 year)
Query!
Secondary outcome [8]
0
0
Duration of Response (DOR) Per IRF
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
From first documented response until PD (approximately 4 years)
Query!
Secondary outcome [9]
0
0
Duration of Complete Remission (DOCR) Per IRF
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
From first documentation of CR until PD (approximately 4 years)
Query!
Secondary outcome [10]
0
0
Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy
Query!
Assessment method [10]
0
0
CR was defined as disappearance of all evidence of disease as determined by an IRF.
Query!
Timepoint [10]
0
0
Baseline up to end of frontline therapy (approximately 4 years)
Query!
Secondary outcome [11]
0
0
Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline up to end of frontline therapy (approximately 4 years)
Query!
Secondary outcome [12]
0
0
Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Cycle 2 Day 25
Query!
Secondary outcome [13]
0
0
A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Query!
Secondary outcome [14]
0
0
A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Query!
Secondary outcome [15]
0
0
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Query!
Secondary outcome [16]
0
0
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Query!
Secondary outcome [17]
0
0
A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
Query!
Assessment method [17]
0
0
The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.
Query!
Timepoint [17]
0
0
Baseline up to end of treatment (approximately 1 year)
Query!
Secondary outcome [18]
0
0
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
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Baseline up to end of treatment (approximately 1 year)
Query!
Eligibility
Key inclusion criteria
1. Treatment-naïve participants with Ann Arbor Stage III or IV HL.
2. Histologically confirmed classical Hodgkin Lymphoma (HL) according to the current World Health Organization (WHO) classification.
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.
4. Bidimensional measurable disease as documented by radiographic technique per the International Working Group Revised Criteria for Response Assessment for Malignant Lymphoma.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Nodular lymphocyte predominant Hodgkin lymphoma.
2. Cerebral/meningeal disease, including signs and symptoms of progressive multifocalleukoencephalopathy (PML).
3. Sensory or motor peripheral neuropathy.
4. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 12 weeks of first study drug dose.
5. Known human immunodeficiency virus (HIV) positive.
6. 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
9/11/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
13/01/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1334
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
- Kingswood
Query!
Recruitment hospital [2]
0
0
- St Leonards
Query!
Recruitment hospital [3]
0
0
- Westmead
Query!
Recruitment hospital [4]
0
0
- South Brisbane
Query!
Recruitment hospital [5]
0
0
- Bedford Park
Query!
Recruitment hospital [6]
0
0
- Hobart
Query!
Recruitment hospital [7]
0
0
- East Melbourne
Query!
Recruitment hospital [8]
0
0
- Geelong
Query!
Recruitment hospital [9]
0
0
- Heidelberg
Query!
Recruitment hospital [10]
0
0
- Parkville
Query!
Recruitment hospital [11]
0
0
- Perth
Query!
Recruitment postcode(s) [1]
0
0
- Kingswood
Query!
Recruitment postcode(s) [2]
0
0
- St Leonards
Query!
Recruitment postcode(s) [3]
0
0
- Westmead
Query!
Recruitment postcode(s) [4]
0
0
- South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
- Bedford Park
Query!
Recruitment postcode(s) [6]
0
0
- Hobart
Query!
Recruitment postcode(s) [7]
0
0
- East Melbourne
Query!
Recruitment postcode(s) [8]
0
0
- Geelong
Query!
Recruitment postcode(s) [9]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [10]
0
0
- Parkville
Query!
Recruitment postcode(s) [11]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Iowa
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nebraska
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Mexico
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
North Dakota
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Ohio
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Oklahoma
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Oregon
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Pennsylvania
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
South Carolina
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Tennessee
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Texas
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Utah
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Virginia
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Washington
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
West Virginia
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Wisconsin
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Antwerpen
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Brugge
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Gent
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Bahia
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Parana
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Rio Grande Do Sul
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Sao Paulo
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Rio De Janeiro
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Sao paulo
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Alberta
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
British Columbia
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Manitoba
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Nova Scotia
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Ontario
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Quebec
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Saskatchewan
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Hradec Kralove
Query!
Country [53]
0
0
Czechia
Query!
State/province [53]
0
0
Prague
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Praha 10
Query!
Country [55]
0
0
Denmark
Query!
State/province [55]
0
0
Aalborg
Query!
Country [56]
0
0
Denmark
Query!
State/province [56]
0
0
Aarhus C
Query!
Country [57]
0
0
Denmark
Query!
State/province [57]
0
0
Copenhagen
Query!
Country [58]
0
0
Denmark
Query!
State/province [58]
0
0
Odense C
Query!
Country [59]
0
0
Denmark
Query!
State/province [59]
0
0
Roskilde
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Cedex
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
La Tronche
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Limoges
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Paris
Query!
Country [64]
0
0
Hong Kong
Query!
State/province [64]
0
0
Kowloon
Query!
Country [65]
0
0
Hong Kong
Query!
State/province [65]
0
0
Hong Kong
Query!
Country [66]
0
0
Hong Kong
Query!
State/province [66]
0
0
Tuen Mun
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Budapest
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Debrecen
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Gyor
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Pecs
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Szeged
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Emilia-Romagna
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Lazio
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Alessandria
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Bologna
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Cagliari
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Cuneo
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Genova
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Milano
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Napoli
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Rionero In Volture
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Rome
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Rozzano
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Torrette Di Ancona
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Fukuoka-city
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Fukuoka
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Hiroshima-city
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Maebashi-city
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Nagoya
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Osaka Prefecture
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Sendai-city
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Chuo-ku
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Isehara-shi
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Koto-ku
Query!
Country [95]
0
0
Korea, Republic of
Query!
State/province [95]
0
0
Gyeonggi
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Jeollanam-do
Query!
Country [97]
0
0
Korea, Republic of
Query!
State/province [97]
0
0
Seoul
Query!
Country [98]
0
0
Korea, Republic of
Query!
State/province [98]
0
0
Busan
Query!
Country [99]
0
0
Korea, Republic of
Query!
State/province [99]
0
0
Daegu
Query!
Country [100]
0
0
Korea, Republic of
Query!
State/province [100]
0
0
Incheon
Query!
Country [101]
0
0
Korea, Republic of
Query!
State/province [101]
0
0
Jeonju
Query!
Country [102]
0
0
Norway
Query!
State/province [102]
0
0
Bergen
Query!
Country [103]
0
0
Norway
Query!
State/province [103]
0
0
Oslo
Query!
Country [104]
0
0
Poland
Query!
State/province [104]
0
0
Gdansk
Query!
Country [105]
0
0
Poland
Query!
State/province [105]
0
0
Katowice
Query!
Country [106]
0
0
Poland
Query!
State/province [106]
0
0
Krakow
Query!
Country [107]
0
0
Poland
Query!
State/province [107]
0
0
L0dz
Query!
Country [108]
0
0
Poland
Query!
State/province [108]
0
0
Olsztyn
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Warszawa
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Wroclaw
Query!
Country [111]
0
0
Russian Federation
Query!
State/province [111]
0
0
Poselok Pesochny
Query!
Country [112]
0
0
Russian Federation
Query!
State/province [112]
0
0
Republic Of Bashkortostan
Query!
Country [113]
0
0
Russian Federation
Query!
State/province [113]
0
0
Republic Tatrstan
Query!
Country [114]
0
0
Russian Federation
Query!
State/province [114]
0
0
Moscow
Query!
Country [115]
0
0
Russian Federation
Query!
State/province [115]
0
0
Moskva
Query!
Country [116]
0
0
Russian Federation
Query!
State/province [116]
0
0
St.Petersburg
Query!
Country [117]
0
0
South Africa
Query!
State/province [117]
0
0
Gauteng
Query!
Country [118]
0
0
South Africa
Query!
State/province [118]
0
0
Kwa Zulu Natal
Query!
Country [119]
0
0
South Africa
Query!
State/province [119]
0
0
Bloemfontein
Query!
Country [120]
0
0
South Africa
Query!
State/province [120]
0
0
Cape Town
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
Badalona
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Barcelona
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Marbella
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
Pamplona
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Salamanca
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Santiago de Compostela
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Valencia
Query!
Country [128]
0
0
Taiwan
Query!
State/province [128]
0
0
Changhua City
Query!
Country [129]
0
0
Taiwan
Query!
State/province [129]
0
0
Chiayi County 613
Query!
Country [130]
0
0
Taiwan
Query!
State/province [130]
0
0
Tainan
Query!
Country [131]
0
0
Taiwan
Query!
State/province [131]
0
0
Taipei
Query!
Country [132]
0
0
Taiwan
Query!
State/province [132]
0
0
Taoyuan County
Query!
Country [133]
0
0
Turkey
Query!
State/province [133]
0
0
Ankara
Query!
Country [134]
0
0
Turkey
Query!
State/province [134]
0
0
Istanbul
Query!
Country [135]
0
0
Turkey
Query!
State/province [135]
0
0
Samsun
Query!
Country [136]
0
0
United Kingdom
Query!
State/province [136]
0
0
Cornwall
Query!
Country [137]
0
0
United Kingdom
Query!
State/province [137]
0
0
Scotland
Query!
Country [138]
0
0
United Kingdom
Query!
State/province [138]
0
0
Surrey
Query!
Country [139]
0
0
United Kingdom
Query!
State/province [139]
0
0
Wales
Query!
Country [140]
0
0
United Kingdom
Query!
State/province [140]
0
0
Birmingham
Query!
Country [141]
0
0
United Kingdom
Query!
State/province [141]
0
0
Canterbury
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
Exeter
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
Inverness
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Leicester
Query!
Country [145]
0
0
United Kingdom
Query!
State/province [145]
0
0
Lincoln
Query!
Country [146]
0
0
United Kingdom
Query!
State/province [146]
0
0
Liverpool
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
London
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Manchester
Query!
Country [149]
0
0
United Kingdom
Query!
State/province [149]
0
0
Norfolk
Query!
Country [150]
0
0
United Kingdom
Query!
State/province [150]
0
0
Northwood
Query!
Country [151]
0
0
United Kingdom
Query!
State/province [151]
0
0
Nottingham
Query!
Country [152]
0
0
United Kingdom
Query!
State/province [152]
0
0
Oxford
Query!
Country [153]
0
0
United Kingdom
Query!
State/province [153]
0
0
Romford
Query!
Country [154]
0
0
United Kingdom
Query!
State/province [154]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Takeda
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Seagen Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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)
Query!
Trial website
https://clinicaltrials.gov/study/NCT01712490
Query!
Trial related presentations / publications
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. 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. 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. doi: 10.1016/S2352-3026(22)00009-6. 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. 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. 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. doi: 10.1056/NEJMx180007. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
Takeda
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/90/NCT01712490/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/90/NCT01712490/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01712490