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RECRUITING

NCT04685616

PHASE3

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

Sponsor: University College, London

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

16 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

1042

Start Date

2022-04-14

Completion Date

2032-09

Last Updated

2026-03-30

Healthy Volunteers

Conditions

Hodgkin Lymphoma

Interventions

RADIATION

Involved site radiotherapy

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

DRUG

Doxorubicin

See arm description

DRUG

Bleomycin

See arm description

DRUG

Brentuximab vedotin

See arm description

DRUG

Vinblastine

See arm description

DRUG

Dacarbazine

See arm description

DRUG

Haematopoietic growth factor

See arm description

Inclusion Criteria: * Males and females aged 16-69 years (inclusive) (age range is 18-69 in US and EU) * Histologically confirmed classical Hodgkin lymphoma * Stage I or II supradiaphragmatic disease with no mediastinal bulk disease (defined as greater than a third of the transthoracic diameter at any level of thoracic vertebra as determined by CT) or B symptoms. Bulky disease at other sites is acceptable. Extranodal disease (single extranodal site (stage I) or contiguous nodal extension (stage II)) is acceptable. * ECOG performance status 0-2. * No previous treatment for Hodgkin lymphoma * Fit to receive anthracycline-based chemotherapy (patients with a history of ischaemic heart disease or hypertension should have a left ventricular ejection fraction of ≥50%) * Creatinine clearance (measured or calculated \>40ml/min * Total bilirubin \<1.5 x upper limit of normal, unless attributable to disease or known Gilbert's syndrome * ALT or AST \< 2 x upper limit of normal * Adequate bone marrow function with neutrophils ≥1.0x10\^9/l and platelets ≥100x10\^9/l * Haemoglobin ≥8g/dL * Willing and able to comply with the requirements of the protocol, including contraceptive advice, where applicable * Written informed consent Exclusion Criteria: * Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg prednisolone (or equivalent) for up to 7 days * Infradiaphragmatic disease * Nodular lymphocyte predominant Hodgkin lymphoma * Absence of FDG-avid lesions on baseline PET scan * Age 70 years or over or age 15 years or under * Other cancer diagnosed with the last 5 years. Patients with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin are not excluded * Recurrent or persistent other cancer within last 5 years irrespective of date of initial diagnosis * Pre-existing grade ≥1 sensory or motor neuropathy from any cause * History of or current progressive multi-focal leukoencephalopathy or other chronic condition of the brain * Symptomatic neurologic disease compromising normal activities of daily living or requiring medications * Infection with HIV, hepatitis C or active hepatitis B infection (surface antigen or DNA positive) * Any active systemic viral, bacterial or fungal infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first trial drug dose * Receiving or recently treated with any other investigational agent (within 4 weeks of trial entry) * Pregnant or breastfeeding women * Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD * Known history of any cardiovascular or respiratory conditions that would preclude anthracycline or bleomycin administration * Other significant medical or psychiatric comorbidity that in the opinion of the investigator would make administration of ABVD or A2VD hazardous

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

Clinical Research Directory

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (70)