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Looking for participantsPhase3

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

Sponsor: University College, London

NCT ID: NCT04685616

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Involved site radiotherapy (radiation), Doxorubicin (drug), Bleomycin (drug), Brentuximab vedotin (drug)
How long the study runs
Study runs about 125 months (dates as stated)
About the drug or intervention
Involved site radiotherapy — radiation: Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines. · Doxorubicin — drug: See arm description · Bleomycin — drug: See arm description · Brentuximab vedotin — drug: See arm description · Vinblastine — drug: See arm description · Dacarbazine — drug: See arm description · Haematopoietic growth factor — drug: See arm description
Patient visit burden
Not specified by the sponsor

In plain English

This trial is looking at brentuximab vedotin as a treatment for people with early stage Hodgkin lymphoma (a cancer of the lymphatic system). It is for people whose disease is in stage I or II, in the upper body, who have not had treatment for Hodgkin lymphoma before. The trial is run by University College, London.

Who can take part

  • People aged 16 to 69 (18 to 69 in the US and EU) with confirmed classical Hodgkin lymphoma
  • Disease at stage I or II in the chest or upper body, above the diaphragm, with no bulky disease in the mediastum (the area between the lungs) and no B symptoms
  • People who are reasonably well and active (performance status 0 to 2)
  • No previous treatment for Hodgkin lymphoma
  • Fit enough for chemotherapy that includes a drug called an anthracycline, including having healthy enough heart, kidneys, liver, bone marrow and blood counts
  • Willing and able to follow the trial plan, including using contraception if it applies, and giving written informed consent

Who may not be able to

  • Anyone who has already had treatment for Hodgkin lymphoma, apart from a short course of steroid tablets (up to 7 days)
  • Disease below the diaphragm (in the lower body)
  • A rarer type called nodular lymphocyte predominant Hodgkin lymphoma
  • No signs of the disease showing up on a baseline PET scan
  • Age under 16 or 70 and over
  • Another cancer diagnosed or returned within the last 5 years (some fully removed skin cancers are allowed)
  • Existing nerve damage (neuropathy) causing symptoms
  • Certain long-term brain conditions, or nerve symptoms that affect daily life or need medicines
  • Infection with HIV, hepatitis C, or active hepatitis B
  • Any active infection needing antibiotic, antiviral or antifungal treatment in the 2 weeks before the first trial dose
  • Taking another experimental drug within 4 weeks of joining the trial
  • Women who are pregnant or breastfeeding
  • Known serious allergy to brentuximab vedotin or any part of the chemotherapy called ABVD
  • Heart or lung conditions that would make ABVD chemotherapy unsafe
  • Any other major medical or mental health problem that the researchers think would make the treatment risky

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Visits, duration and what taking part involves: not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
16 Years to 69 Years
Who
All
Number of participants
1,042
Started
2022-04-14
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for hodgkin lymphoma
  • • Phase3 - 1,042 participants
  • • RADAR is a multicentre, international, randomised, open-label phase III clinical trial composed of 2 trials running in parallel

Who can take part?

  • • Ages 16 Years to 69 Years
  • • Diagnosed with hodgkin lymphoma

Where?

  • • Basingstoke - Hampshire Hospitals NHS Foundation Trust
  • • Blackpool - Blackpool Victoria Hospital
  • • Newcastle upon Tyne - Freeman Hospital, Newcastle
  • • Glasgow - Lanarkshire
  • • +27 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Hodgkin Lymphoma

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 69 Years
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

DNA positive

What the study is looking for

  • ✓Males and females aged 16-69 years (inclusive) (age range is 18-69 in US and EU)
  • ✓confirmed by a biopsy classical Hodgkin lymphoma
  • ✓ECOG performance status 0-2.
  • ✓No previous treatment for Hodgkin lymphoma
  • ✓Fit to receive anthracycline-based drug treatment (patients with a history of ischaemic heart disease or hypertension...

Who cannot take part

  • ✗Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg...
  • ✗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
See the full criteria
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

Where Is This Study? (31 UK sites)

Hampshire Hospitals NHS Foundation Trust

Basingstoke RG24 9NA, United Kingdom

Recruiting
Site contact (verified)
Katie SmithPrincipal Investigator

Blackpool Victoria Hospital

Blackpool FY3 8NR, United Kingdom

Recruiting
Site contact (verified)
Mac MachetaPrincipal Investigator

Freeman Hospital, Newcastle

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Wendy OsbornePrincipal Investigator

Lanarkshire

Glasgow G71 8BB, United Kingdom

Recruiting
Site contact (verified)
Charlotte ThomasPrincipal Investigator

St George's Hospital

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)
Ruth PettengellPrincipal Investigator

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Site contact (verified)
Dominic CulliganPrincipal Investigator

University Hospitals Birmingham

Birmingham B15 2GW, United Kingdom

Recruiting
Site contact (verified)
Lindsay GeorgePrincipal Investigator

Glan Clwyd Hospital

Bodelwyddan LL18 5UJ, United Kingdom

Recruiting
Site contact (verified)
Earnest HeartinPrincipal Investigator

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

Recruiting
Site contact (verified)
Claire BurneyPrincipal Investigator

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

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Eve Gallop-EvansPrincipal Investigator

Colchester Hospital, ESNEFT

Colchester CO4 5JL, United Kingdom

Recruiting
Site contact (verified)
Gavin CampbellPrincipal Investigator

University Hospital Coventry

Coventry CV2 2DX, United Kingdom

Recruiting
Site contact (verified)
Duncan MurrayPrincipal Investigator

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Site contact (verified)
Pam McKayPrincipal Investigator

Castle Hill Hospital

Hull HU16 5JQ, United Kingdom

Recruiting
Site contact (verified)
Russell PatmorePrincipal Investigator

St James University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Catherine BurtonPrincipal Investigator
Catherine Burtoncathy.burton1@nhs.net

University Hospitals of Leicester NHS Trust

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Sapna LadaniPrincipal Investigator

The Clatterbridge Cancer Centre NHSFT, 65 Pembroke Place

Liverpool L7 8YA, United Kingdom

Recruiting
Site contact (verified)
Nagesh KalakondaPrincipal Investigator

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Rebecca AuerPrincipal Investigator

University College London Hospitals NHS Foundation Trust (UCLH)

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Maria MarzoliniPrincipal Investigator

Royal Marsden Hospital Chelsea

London SW3 6JZ, United Kingdom

Recruiting
Site contact (verified)
Sunil IyengarPrincipal Investigator

Christie Hospital

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Beth PhillipsPrincipal Investigator

Norfolk & Norwich University Hospital

Norwich NR4 7UY, United Kingdom

Recruiting
Site contact (verified)
Nimish ShahPrincipal Investigator

Nottingham University Hospitals NHST

Nottingham NG51PB, United Kingdom

Recruiting
Site contact (verified)
Emily ChernuchaPrincipal Investigator

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Graham CollinsPrincipal Investigator

Derriford Hospital

Plymouth PL6 8DH, United Kingdom

Recruiting
Site contact (verified)
Patrick MeddPrincipal Investigator

Royal Hallamshire Hospital

Sheffield S10 2JF, United Kingdom

Recruiting
Site contact (verified)
Nick MorleyPrincipal Investigator

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
Andrew DaviesPrincipal Investigator

Sunderland Royal Hospital

Sunderland SR4 7TP, United Kingdom

Recruiting
Site contact (verified)
Scott MarshallPrincipal Investigator

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Sunil IyengarPrincipal Investigator

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)
Deborah TurnerPrincipal Investigator

Royal Cornwall Hospital

Truro TR1 3LJ, United Kingdom

Recruiting
Site contact (verified)
Bryson PottingerPrincipal Investigator

How to Get in Touch

RADAR Trial Coordinator

Sponsor contact

CONTACT

+44(0)207 679 9860 ctc.radar@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03