RecruitingPhase 3NCT04685616

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +/- ISRT With A2VD +/- ISRT in Patients With Previously Untreated Stage IA/IIA Hodgkin Lymphoma

Sponsor

University College, London

Enrollment

1,042 participants

Start Date

Apr 14, 2022

Study Type

INTERVENTIONAL

Conditions

Hodgkin Lymphoma

Summary

RADAR is a multicentre, international, randomised, open-label phase III clinical trial composed of 2 trials running in parallel. Trial 1 will be led and sponsored by University College London (UCL) and conducted in Europe and Australia/New Zealand. Trial 2 will be led by the Canadian Cancer Trials Group (CCTG) and conducted in North America, with CCTG the regulatory sponsor in Canada, and University of Miami the regulatory sponsor and IND holder in the US. Datasets from Trial 1 and Trial 2 will be combined to achieve the total sample size. Data analysis will be performed by UCL and therefore UCL is responsible for the clinicaltrials.gov entry. Eligible patients will be randomised to receive either ABVD or A2VD chemotherapy. An interim PET-CT scan will be performed after 2 cycles of treatment, which will be used to adapt subsequent treatment. Patients will receive a total of 3-4 cycles of chemotherapy and may also receive involved site radiotherapy as consolidation. Patients will be followed up for a minimum of 5 years after treatment.

Eligibility

Min Age: 16 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new chemotherapy regimen using brentuximab vedotin (a targeted drug) combined with standard chemotherapy for young people with early-stage Hodgkin lymphoma, to see if it works better than the current standard treatment. **You may be eligible if...** - You are between 16 and 69 years old (18–69 in the US and EU) - You have been newly diagnosed with early-stage classical Hodgkin lymphoma (stage I or II) - Your disease is above the diaphragm and does not involve a large mass in the chest or B symptoms (fever, night sweats, weight loss) - You have not received any previous treatment for Hodgkin lymphoma - Your heart function is adequate (ejection fraction ≥ 50% if you have heart history) **You may NOT be eligible if...** - You have already been treated for Hodgkin lymphoma - Your cancer is at a more advanced stage - You are not healthy enough for combination chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONInvolved site radiotherapy

Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines. Recommended dose 30Gy

DRUGDoxorubicin

See arm description

DRUGBleomycin

See arm description

DRUGBrentuximab vedotin

See arm description

DRUGVinblastine

See arm description

DRUGDacarbazine

See arm description

DRUGHaematopoietic growth factor

See arm description

Locations(70)

Stanford University - (Stanford Cancer Institute)

Stanford, California, United States

University of Miami School of Medicine

Miami, Florida, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Townsville University Hospital

Townsville, Queensland, Australia

Royal Adelaide Hospital

Adelaide, Australia

Box Hill Hospital

Box Hill, Australia

Royal Brisbane and Women's Hospital

Brisbane, Australia

Royal Darwin Hospital

Darwin, Australia

Liverpool Hospital

Liverpool, Australia

Sunshine Hospital (Western Health)

Melbourne, Australia

Concord Repatriation General Hospital

Sydney, Australia

St George Hospital

Sydney, Australia

AZ Delta Campus Rumbeke

Roeselare, West Flanders, Belgium

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

UZ Leuven

Leuven, Belgium

CHU-UCL Namur

Namur, Belgium

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Ottowa Hospital Research Institute

Ottawa, Canada

Saint John Regional Hospital

Saint John, Canada

University Health Network Princess Margaret Cancer Centre

Toronto, Canada

Vancouver Cancer Centre

Vancouver, Canada

CancerCare Manitoba

Winnipeg, Canada

Aarhus University Hospitak Skjeby

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

St James's Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

Amsterdam UMC - location VUMC

Amsterdam, Netherlands

Reinier de Graafweg 3-11 - Postbus 5011 - 2625 AD Delft

Delft, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Radboud University Medical Center Nijmegen

Nijmegen, Netherlands

NL 331 - Haaglanden Medisch Centrum (HMC) - Haaglanden MC

The Hague, Netherlands

Auckland City Hospital

Auckland, New Zealand

Instituto Portugues de Oncologia de Lisboa Francisco Gentil

Lisbon, Portugal

Narodny Onkologicky Ustav

Bratislava, Slovakia

Hospital Del Mar

Barcelona, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Complejo Hospitalario de Navarra

Pamplona, Spain

University Hospital of Wales, Cardiff & Vale University Local Health Board

Cardiff, Cardiff, United Kingdom

Blackpool Victoria Hospital

Blackpool, Lancashire, United Kingdom

Freeman Hospital, Newcastle

Newcastle upon Tyne, Newcastle, United Kingdom

Nottingham University Hospitals NHST

Nottingham, Nottingham, United Kingdom

Lanarkshire

Glasgow, Scotland, United Kingdom

St George's Hospital

London, Tooting, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

University Hospitals Birmingham

Birmingham, United Kingdom

Glan Clwyd Hospital

Bodelwyddan, United Kingdom

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Colchester Hospital, ESNEFT

Colchester, United Kingdom

University Hospital Coventry

Coventry, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Castle Hill Hospital

Hull, United Kingdom

St James University Hospital

Leeds, United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

The Clatterbridge Cancer Centre NHSFT, 65 Pembroke Place

Liverpool, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

University College London Hospitals NHS Foundation Trust (UCLH)

London, United Kingdom

Royal Marsden Hospital Chelsea

London, United Kingdom

Christie Hospital

Manchester, United Kingdom

Norfolk & Norwich University Hospital

Norwich, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Sunderland Royal Hospital

Sunderland, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

Torbay Hospital

Torquay, United Kingdom

Royal Cornwall Hospital

Truro, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04685616

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