Recruiting

Phase 3

Brentuximab VedotinBrentuximab Vedotin in Early Stage Hodgkin Lymphoma

Sponsor:

University College, London

Code:

NCT04685616

Conditions

Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 16 - 69

Healthy Volunteers: Not accepted

Interventions

Involved site radiotherapy

Doxorubicin

Bleomycin

Brentuximab vedotin

Vinblastine

Study Details

Brief 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.

Conditions

Hodgkin Lymphoma

Study ID

NCT04685616

Start date

Apr 14, 2022

Status verified date

Mar, 2026

Completion date

Sep, 2032

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 69

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1042 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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

Primary outcome measure

Progression free survival (PFS) [ Time Frame: 3 years from end of treatment ]

Central Contacts and Locations

Central contacts

RADAR Trial Coordinator

+44(0)207 679 9860 ctc.radar@ucl.ac.uk

Locations

Stanford University - (Stanford Cancer Institute)

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

Ranjana Advani

University of Miami School of Medicine

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Craig Moskowitz

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Alison Moskowitz

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Principal Investigator:

Nicholas Forward

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Principal Investigator:

Joanne Britto

Ottowa Hospital Research Institute

Recruiting

Ottawa, Canada, K1Y 4E9

Principal Investigator:

Isabelle Bence-Bruckler

Saint John Regional Hospital

Recruiting

Saint John, Canada, E2L 4L2

Principal Investigator:

Alfonso Riviera Duarte

University Health Network Princess Margaret Cancer Centre

Recruiting

Toronto, Canada, M5G 2M9

Principal Investigator:

Michael Crump

Vancouver Cancer Centre

Recruiting

Vancouver, Canada, V5Z 4E6

Principal Investigator:

Kerry Savage

CancerCare Manitoba

Recruiting

Winnipeg, Canada, R3E 0V9

Principal Investigator:

Leonard Minuk

More Information

Sponsor

University College, London

Last update posted

Jul 8, 2026

Last verified

Mar, 2026

Keywords

PET-response adapted
Stage IA/IIA Hodgkin lymphoma
Brentuximab vedotin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University College, London on 2026-07-08.