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Clinical Trials in Canada / NCT04685616
Recruiting Phase 3

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

NCT04685616 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2022-04-14
Last updated
2026-07-08

Condition(s) studied

Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

Involved site radiotherapyDoxorubicin →Bleomycin →Brentuximab vedotin →Vinblastine →Dacarbazine →Haematopoietic growth factor

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

Study 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

Sex
ALL
Min age
16 Years
Max age
69 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
Stanford University - (Stanford Cancer Institute) Stanford California Recruiting
University of Miami School of Medicine Miami Florida Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Royal North Shore Hospital Saint Leonards New South Wales Recruiting
Townsville University Hospital Townsville Queensland Recruiting
Royal Adelaide Hospital Adelaide Australia Recruiting
Box Hill Hospital Box Hill Australia Recruiting
Royal Brisbane and Women's Hospital Brisbane Australia Recruiting
Royal Darwin Hospital Darwin Australia Recruiting
Liverpool Hospital Liverpool Australia Recruiting
Sunshine Hospital (Western Health) Melbourne Australia Recruiting
Concord Repatriation General Hospital Sydney Australia Recruiting
St George Hospital Sydney Australia Recruiting
AZ Delta Campus Rumbeke Roeselare West Flanders Recruiting
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
Ziekenhuis Netwerk Antwerpen Antwerp Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHU-UCL Namur Namur Belgium Recruiting
QEII Health Sciences Centre Halifax Nova Scotia Recruiting
Juravinski Cancer Centre Hamilton Ontario Recruiting
Ottowa Hospital Research Institute Ottawa Canada Recruiting
Saint John Regional Hospital Saint John Canada Recruiting
University Health Network Princess Margaret Cancer Centre Toronto Canada Recruiting
Vancouver Cancer Centre Vancouver Canada Recruiting
CancerCare Manitoba Winnipeg Canada Recruiting
Aarhus University Hospitak Skjeby Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
St James's Hospital Dublin Ireland Recruiting
St. Vincent's University Hospital Dublin Ireland Recruiting
University Hospital Galway Galway Ireland Recruiting
Amsterdam UMC - location VUMC Amsterdam Netherlands Recruiting
Reinier de Graafweg 3-11 - Postbus 5011 - 2625 AD Delft Delft Netherlands Recruiting
Universitair Medisch Centrum Groningen Groningen Netherlands Recruiting
Radboud University Medical Center Nijmegen Nijmegen Netherlands Recruiting
NL 331 - Haaglanden Medisch Centrum (HMC) - Haaglanden MC The Hague Netherlands Recruiting
Auckland City Hospital Auckland New Zealand Recruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil Lisbon Portugal Recruiting
Narodny Onkologicky Ustav Bratislava Slovakia Recruiting
Hospital Del Mar Barcelona Spain Recruiting
Institut Catala d'Oncologia Barcelona Spain Recruiting

+ 32 more sites — see the full list on the official registry below.

On this site

📄 Adcetris (brentuximab vedotin) drug profile →

More University College, London trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04685616 on ClinicalTrials.gov ↗ ← All trials in Canada