Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
ConditionHodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-69
SponsorUniversity College, London
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Involved site radiotherapy
- Doxorubicin
- Bleomycin
- Brentuximab vedotin
- Vinblastine
- Dacarbazine
- Haematopoietic growth factor
Treatment groups
1,042 Participants
are divided into 2 treatment groupsSponsors and collaborators
University College, London
Lead sponsor
Takeda
Collaborator
University of Miami
Collaborator
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator
Australasian Leukaemia and Lymphoma Group
Collaborator
Seagen Inc.
Collaborator
Canadian Cancer Trials Group
Collaborator
Source ClinicalTrials.gov