Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1042 participants
INTERVENTIONAL
2022-04-14
2032-09-30
Brief Summary
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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.
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Detailed Description
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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* Patients with Deauville score 5 will be withdrawn from trial treatment.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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ABVD +/- ISRT
2 x 28 day cycles of ABVD: Doxorubicin 25mg/m\^2 IV days 1 \& 15 Bleomycin 10000 IU/m\^2 days 1 \& 15 Vinblastine 6mg/m\^2 days 1 \& 15 Dacarbazine 375mg/m\^2 days 1 \& 15
PET-CT after 2 cycles will determine subsequent treatment:
Deauville score 1-3 (PET CMR): 1 further cycle of ABVD then follow up Deauville score 4 (PET positive): 2 further cycles of ABVD followed by involved site radiotherapy (ISRT) Deauville score 5: withdraw from trial treatment; further treatment will be given at the treating clinician's discretion. Enter follow up for the trial.
Involved site radiotherapy
Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines.
Recommended dose 30Gy
Doxorubicin
See arm description
Bleomycin
See arm description
Vinblastine
See arm description
Dacarbazine
See arm description
A2VD +/- ISRT
2 x 28 day cycles of A2VD: Doxorubicin 25mg/m\^2 IV days 1 \& 15 Brentuximab vedotin 1.2mg/kg (max 120mg) days 1 \& 15 Vinblastine 6mg/m\^2 days 1 \& 15 Dacarbazine 375mg/m\^2 days 1 \& 15 Filgrastim (or equivalent haematopoietic growth factor) for 5-7 days from day 2 and day 16 (or single dose of peg-filgrastim on days 2 \& 16)
PET-CT after 2 cycles will determine subsequent treatment:
Deauville score 1-3 (PET CMR): 1 further cycle of A2VD then follow up Deauville score 4 (PET positive): 2 further cycles of A2VD followed by involved site radiotherapy (ISRT) Deauville score 5: withdraw from trial treatment; further treatment will be given at the treating clinician's discretion. Enter follow up for the trial.
Involved site radiotherapy
Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines.
Recommended dose 30Gy
Doxorubicin
See arm description
Brentuximab vedotin
See arm description
Vinblastine
See arm description
Dacarbazine
See arm description
Haematopoietic growth factor
See arm description
Interventions
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Involved site radiotherapy
Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines.
Recommended dose 30Gy
Doxorubicin
See arm description
Bleomycin
See arm description
Brentuximab vedotin
See arm description
Vinblastine
See arm description
Dacarbazine
See arm description
Haematopoietic growth factor
See arm description
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
69 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
University of Miami
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Australasian Leukaemia and Lymphoma Group
OTHER
Seagen Inc.
INDUSTRY
Canadian Cancer Trials Group
NETWORK
University College, London
OTHER
Responsible Party
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Principal Investigators
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John Radford
Role: PRINCIPAL_INVESTIGATOR
University of Manchester / Christie Hospital, Manchester
Locations
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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
Ziekenhuis Netwerk Antwerpen
Antwerp, , Belgium
UZ Leuven
Leuven, , Belgium
CHU-UCL Namur
Namur, , Belgium
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
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
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
Countries
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Central Contacts
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Facility Contacts
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Austin Yeung
Role: primary
Safia Sawleh
Role: primary
Pamela Park
Role: primary
Keith Fay
Role: primary
Pratyush Giri
Role: primary
Denise Lee
Role: primary
Nicholas Weber
Role: primary
Emma Palfreyman
Role: primary
Michael Gilbertson
Role: primary
Nicole Wong Doo
Role: primary
Fernando Roncolato
Role: primary
Edna Wilson
Role: primary
Ashley-Ann Emond
Role: primary
Sharon Turnell
Role: primary
Marie Kirchmeyer
Role: primary
Niamh McMahon
Role: primary
Tianna Rarama
Role: primary
Sanne Tonnio
Role: primary
Posthuma Ward
Role: primary
Leanne Berkahn
Role: primary
Sureda-Balari Anna
Role: primary
Eve Gallop-Evans
Role: primary
Mac Macheta
Role: primary
Wendy Osborne
Role: primary
Emily Chernucha
Role: primary
Charlotte Thomas
Role: primary
Ruth Pettengell
Role: primary
Role: backup
Dominic Culligan
Role: primary
Claire Burney
Role: primary
Pam McKay
Role: primary
Russell Patmore
Role: primary
Sapna Ladani
Role: primary
Nagesh Kalakonda
Role: primary
Rebecca Auer
Role: primary
Maria Marzolini
Role: primary
Nimish Shah
Role: primary
Graham Collins
Role: primary
Patrick Medd
Role: primary
Deborah Turner
Role: primary
Bryson Pottinger
Role: primary
References
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Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
Other Identifiers
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2020-005160-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IISR X25041
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UCL/15/0105
Identifier Type: OTHER
Identifier Source: secondary_id
CCTG HD.12
Identifier Type: OTHER
Identifier Source: secondary_id
IRB number 20230081
Identifier Type: OTHER
Identifier Source: secondary_id
RADAR
Identifier Type: -
Identifier Source: org_study_id
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