Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
Start Date
4/14/2022
Completion Date
9/1/2032
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.
Detailed Description
Eligible patients will be randomised to receive either ABVD chemotherapy (doxorubicin, bleomycin, vinblastine and dacarbazine) or A2VD chemotherapy (doxorubicin, brentuximab vedotin, vinblastine and dacarbazine, with growth factor support). If patients agree, they will have a PET-CT scan after 1 cycle (PET1). The result of this scan will be blinded and used for exploratory endpoints only. Treatment will not be influenced by the result of this scan. All patients will have a PET-CT scan after 2 cycles of treatment (PET2) which will be centrally reviewed. The Deauville score from central review will be used to risk adapt subsequent therapy as follows: * Patients with Deauville score 1-3 will have one further cycle of their randomised chemotherapy and then enter follow up. * Patients with Deauville score 4 will have two further cycles of their randomised chemotherapy followed by involved site radiotherapy * Patients with Deauville score 5 will be withdrawn from trial treatment. They will have further treatment at their treating clinician's discretion and will enter follow up for the trial. Patients with Deauville score 4 on PET2 will have a final PET-CT scan to confirm adequate treatment response. Patients will be followed up for a minimum of 5 years after completing treatment.
Eligibility Criteria
Age Range: 16 years to 69 years
Interventions
Involved site radiotherapy
Doxorubicin
Bleomycin
Brentuximab vedotin
Vinblastine
Dacarbazine
Haematopoietic growth factor
Conditions
Locations
Stanford University - (Stanford Cancer Institute)
Stanford, California 94305
United States
University of Miami School of Medicine
Miami, Florida 33136
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Royal North Shore Hospital
Saint Leonards, New South Wales 2065
Australia
Townsville University Hospital
Townsville, Queensland QLD 4814
Australia
Royal Adelaide Hospital
Adelaide, 5000
Australia
Box Hill Hospital
Box Hill, VIC 3128
Australia
Royal Brisbane and Women's Hospital
Brisbane, QLD 4006
Australia
Royal Darwin Hospital
Darwin, NT 0810
Australia
Liverpool Hospital
Liverpool,
Australia
Sunshine Hospital (Western Health)
Melbourne, VIC 3021
Australia
Concord Repatriation General Hospital
Sydney, NSW 2139
Australia
St George Hospital
Sydney, NSW 2217
Australia
AZ Delta Campus Rumbeke
Roeselare, West Flanders Deltalaan 1, 8800
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 B3H 3A7
Canada
Juravinski Cancer Centre
Hamilton, Ontario L8V 5C2
Canada
Ottowa Hospital Research Institute
Ottawa, K1Y 4E9
Canada
Saint John Regional Hospital
Saint John, E2L 4L2
Canada
University Health Network Princess Margaret Cancer Centre
Toronto, M5G 2M9
Canada
Vancouver Cancer Centre
Vancouver, V5Z 4E6
Canada
CancerCare Manitoba
Winnipeg, R3E 0V9
Canada
Aarhus University Hospitak Skjeby
Aarhus,
Denmark
Rigshospitalet
Copenhagen,
Denmark
St James's Hospital
Dublin,
Ireland
St. Vincent's University Hospital
Dublin,
Ireland
University Hospital Galway
Galway,
Ireland
Amsterdam UMC - location VUMC
Amsterdam, 1081 HV
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, 1023
New Zealand
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Lisbon,
Portugal
Narodny Onkologicky Ustav
Bratislava,
Slovakia
Hospital Del Mar
Barcelona, ES 08003
Spain
Institut Catala d'Oncologia
Barcelona, ES 08908
Spain
Complejo Hospitalario de Navarra
Pamplona,
Spain
Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire RG24 9NA
United Kingdom
Blackpool Victoria Hospital
Blackpool, Lancashire FY3 8NR
United Kingdom
Freeman Hospital, Newcastle
Newcastle upon Tyne, Newcastle NE7 7DN
United Kingdom
Lanarkshire
Glasgow, Scotland G71 8BB
United Kingdom
St George's Hospital
London, Tooting SW17 0QT
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United Kingdom
University Hospitals Birmingham
Birmingham, B15 2GW
United Kingdom
Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ
United Kingdom
Bristol Haematology and Oncology Centre
Bristol,
United Kingdom
University Hospital of Wales, Cardiff & Vale University Local Health Board
Cardiff, CF14 4XW
United Kingdom
Colchester Hospital, ESNEFT
Colchester, CO4 5JL
United Kingdom
University Hospital Coventry
Coventry, CV2 2DX
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United Kingdom
Castle Hill Hospital
Hull, HU16 5JQ
United Kingdom
St James University Hospital
Leeds, LS9 7TF
United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
United Kingdom
The Clatterbridge Cancer Centre NHSFT, 65 Pembroke Place
Liverpool, L7 8YA
United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
University College London Hospitals NHS Foundation Trust (UCLH)
London, NW1 2BU
United Kingdom
Royal Marsden Hospital Chelsea
London, SW3 6JZ
United Kingdom
Christie Hospital
Manchester, M20 4BX
United Kingdom
Norfolk & Norwich University Hospital
Norwich, NR4 7UY
United Kingdom
Nottingham University Hospitals NHST
Nottingham, NG51PB
United Kingdom
Churchill Hospital
Oxford, OX3 7LE
United Kingdom
Derriford Hospital
Plymouth, PL6 8DH
United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF
United Kingdom
Southampton General Hospital
Southampton, SO16 6YD
United Kingdom
Sunderland Royal Hospital
Sunderland, SR4 7TP
United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT
United Kingdom
Torbay Hospital
Torquay, TQ2 7AA
United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ
United Kingdom