A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma

February 12, 2026 updated by: Takeda

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma

Study Type

Interventional

Enrollment (Actual)

1334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia
      • St Leonards, New South Wales, Australia
      • Westmead, New South Wales, Australia
    • Queensland
      • South Brisbane, Queensland, Australia
    • South Australia
      • Bedford Park, South Australia, Australia
    • Tasmania
      • Hobart, Tasmania, Australia
    • Victoria
      • East Melbourne, Victoria, Australia
      • Geelong, Victoria, Australia
      • Heidelberg, Victoria, Australia
      • Parkville, Victoria, Australia
    • Western Australia
      • Perth, Western Australia, Australia
  • Belgium
      • Antwerp, Belgium
      • Bruges, Belgium
      • Ghent, Belgium
  • Brazil
      • Rio de Janeiro, Brazil
      • São Paulo, Brazil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil
    • Paraná
      • Curitiba, Paraná, Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • Czechia
      • Hradec Králové, Czechia
      • Prague, Czechia
  • Denmark
      • Aalborg, Denmark
      • Aarhus C, Denmark
      • Copenhagen, Denmark
      • Odense C, Denmark
      • Roskilde, Denmark
  • France
      • La Tronche, France
      • Limoges, France
      • Paris, France
    • Cedex
      • Argenteuil, Cedex, France
  • Hong Kong
      • Hong Kong, Hong Kong
      • Tuenmen, Hong Kong
    • Kowloon
      • Lai Chi Kok, Kowloon, Hong Kong
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Győr, Hungary
      • Pécs, Hungary
      • Szeged, Hungary
  • Italy
      • Alessandria, Italy
      • Bologna, Italy
      • Cagliari, Italy
      • Cuneo, Italy
      • Genova, Italy
      • Milan, Italy
      • Napoli, Italy
      • Rionero in Volture, Italy
      • Rome, Italy
      • Rozzano, Italy
      • Torrette Di Ancona, Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy
    • Lazio
      • Rome, Lazio, Italy
  • Japan
      • Chūōku, Japan
      • Isehara-shi, Japan
      • Kōtoku, Japan
    • Fukuoka
      • Higashiku, Fukuoka, Japan
    • Fukuoka-city
      • Minamiku, Fukuoka-city, Japan
    • Hiroshima-city
      • Minamiku, Hiroshima-city, Japan
    • Maebashi-city
      • Shōwamachi, Maebashi-city, Japan
    • Nagoya
      • Chikusa-ku, Nagoya, Japan
    • Osaka
      • Suita, Osaka, Japan
    • Sendai-city
      • Aoba-ku, Sendai-city, Japan
  • Norway
      • Bergen, Norway
      • Oslo, Norway
  • Poland
      • Gdansk, Poland
      • Katowice, Poland
      • Krakow, Poland
      • L0dz, Poland
      • Olsztyn, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
  • Russia
      • Moscow, Russia
      • Moskva, Russia
      • Saint Petersburg, Russia
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Russia
    • Poselok Pesochny
      • Saint Petersburg, Poselok Pesochny, Russia
    • Republic Tatrstan
      • Kazan', Republic Tatrstan, Russia
  • South Africa
      • Bloemfontein, South Africa
      • Cape Town, South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa
      • Pretoria, Gauteng, South Africa
    • KwaZulu-Natal
      • eManzimtoti, KwaZulu-Natal, South Africa
  • South Korea
      • Busan, South Korea
      • Daegu, South Korea
      • Incheon, South Korea
      • Jeonju, South Korea
      • Seoul, South Korea
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea
    • Jeollanam-do
      • Hwasun-gun, Jeollanam-do, South Korea
    • Seoul
      • Seocho-gu, Seoul, South Korea
  • Spain
      • Badalona, Spain
      • Barcelona, Spain
      • Marbella, Spain
      • Pamplona, Spain
      • Salamanca, Spain
      • Santiago de Compostela, Spain
      • Valencia, Spain
  • Taiwan
      • Changhua, Taiwan
      • Chiayi County 613, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
      • Samsun, Turkey (Türkiye)
  • United Kingdom
      • Birmingham, United Kingdom
      • Canterbury, United Kingdom
      • Exeter, United Kingdom
      • Inverness, United Kingdom
      • Leicester, United Kingdom
      • Lincoln, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norfolk, United Kingdom
      • Northwood, United Kingdom
      • Nottingham, United Kingdom
      • Oxford, United Kingdom
      • Romford, United Kingdom
      • Southampton, United Kingdom
    • Cornwall
      • Truro, Cornwall, United Kingdom
    • Scotland
      • Aberdeen, Scotland, United Kingdom
      • Glasgow, Scotland, United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Gilbert, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Burbank, California, United States
      • Duarte, California, United States
      • Fresno, California, United States
      • Fullerton, California, United States
      • La Jolla, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Sacramento, California, United States
      • San Luis Obispo, California, United States
      • Santa Barbara, California, United States
      • Santa Monica, California, United States
      • Stanford, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Lonetree, Colorado, United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States
    • Florida
      • Fort Myers, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Lawrenceville, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Maywood, Illinois, United States
      • Niles, Illinois, United States
      • Zion, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Goshen, Indiana, United States
      • Indianapolis, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Fairway, Kansas, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Bethesda, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Springfield, Missouri, United States
      • St Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
      • Hackensack, New Jersey, United States
      • Morristown, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Commack, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
      • Rockville Centre, New York, United States
      • The Bronx, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greenville, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Kennewick, Washington, United States
      • Seattle, Washington, United States
      • Vancouver, Washington, United States
      • Yakima, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: brentuximab vedotin
Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
Other Names:
  • SGN-35
  • ADCETRIS®
Drug: doxorubicin
Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Other Names:
  • Adriamycin
Drug: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: dacarbazine
Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Other Names:
  • DTIC
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.
Drug: doxorubicin
Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Other Names:
  • Adriamycin
Drug: vinblastine
Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
Drug: dacarbazine
Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
Other Names:
  • DTIC
Drug: bleomycin
Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)
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)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline until death (approximately up to 4 years)
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.
Baseline until death (approximately up to 4 years)
Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF
Time Frame: Baseline up to end of randomized regimen (approximately 1 year)
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.
Baseline up to end of randomized regimen (approximately 1 year)
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)
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Number of Participants With Abnormal Clinical Laboratory Values
Time Frame: Baseline up to 30 days after last dose of study drug (approximately 1 year)
Baseline up to 30 days after last dose of study drug (approximately 1 year)
Event-free Survival (EFS) Per IRF
Time Frame: Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
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.
Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)
Disease-free Survival (DFS) Per IRF
Time Frame: From CR until PD or death (approximately up to 4 years)
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.
From CR until PD or death (approximately up to 4 years)
Overall Response Rate (ORR) Per IRF
Time Frame: Baseline up to end of randomized regimen (approximately 1 year)
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.
Baseline up to end of randomized regimen (approximately 1 year)
Duration of Response (DOR) Per IRF
Time Frame: From first documented response until PD (approximately 4 years)
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.
From first documented response until PD (approximately 4 years)
Duration of Complete Remission (DOCR) Per IRF
Time Frame: From first documentation of CR until PD (approximately 4 years)
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.
From first documentation of CR until PD (approximately 4 years)
Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy
Time Frame: Baseline up to end of frontline therapy (approximately 4 years)
CR was defined as disappearance of all evidence of disease as determined by an IRF.
Baseline up to end of frontline therapy (approximately 4 years)
Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy
Time Frame: Baseline up to end of frontline therapy (approximately 4 years)
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.
Baseline up to end of frontline therapy (approximately 4 years)
Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2
Time Frame: Cycle 2 Day 25
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.
Cycle 2 Day 25
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
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
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
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
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
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
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
Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin
Time Frame: Baseline up to end of treatment (approximately 1 year)
The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.
Baseline up to end of treatment (approximately 1 year)
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
Time Frame: Baseline up to end of treatment (approximately 1 year)
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.
Baseline up to end of treatment (approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Collaborators

Seagen Inc.

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2012

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

October 19, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimated)

October 23, 2012

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C25003
  • 2011-005450-60 (EudraCT Number)
  • U1111-1161-4937 (Registry Identifier: WHO)
  • 12/LO/1950 (Registry Identifier: NRES)
  • JapicCTI-142491 (Registry Identifier: JapicCTI)
  • REec-2013-0114 (Registry Identifier: REec)
  • 1025002760 (Registry Identifier: TCTIN)
  • C25003CTID (Other Identifier: Israel)
  • 2023-506419-16-00 (Ctis: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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