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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Involved site radiotherapy

    Radiation

    Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines. Recommended dose 30Gy

  • 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

Treatment groups

1,042 Participants
are divided into 2 treatment groups
Group A: ABVD +/- ISRTActive comparator 5 interventions
Group B: A2VD +/- ISRTExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Time from randomisation to first date of progression or death

Time frame
3 years from end of treatment

Secondary outcomes

1

PET-CMR (complete metabolic response) rate

Proportion of patients who have Deauville score 1-3 on PET-CT scan

Time frame
At the end of cycle 2 (each cycle is 28 days)
2

Event-free survival (EFS)

Time from randomisation to first date of progression, death or a positive PET2 scan (whichever occurs first)

Time frame
5 years from end of treatment
3

Overall survival (OS)

Time from randomisation to death

Time frame
5 years from end of treatment
4

Incidence of second cancers and cardiovascular disease

Proportion in each arm who develop a second cancer or cardiovascular disease

Time frame
5 years from end of treatment

Other outcomes

1

Prognostic power of PET after 1 and 2 cycles of ABVD/A2VD

7A Associations between PET1 Deauville score (DS) and PET2 DS; 7B Associations between PET1 DS and EFS; 7C Associations between PET1 DS and OS; 7D Associations between PET1 DS and PFS; 7E Associations between PET2 DS and EFS; 7F Associations between PET2 DS and OS; 7G Associations between PET2 DS and PFS; 7H Associations between EORTC baseline stratification and PET1 DS; 7I Associations between EORTC baseline stratification and PET2 DS; 7J Associations between EORTC baseline stratification and EFS; 7K Associations between EORTC baseline stratification and OS; 7L Associations between EORTC baseline stratification and EFS; 7M Associations between GHSG baseline stratification and PET1 DS; 7N Associations between GHSG baseline stratification and PET2 DS; 7O Associations between GHSG baseline stratification and EFS; 7P Associations between GHSG baseline stratification and OS; 7Q Associations between GHSG baseline stratification and EFS

Time frame
Up to 5 years after end of treatment
2

Prognostic and predictive power of baseline PET features

The association of baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PFS/EFS/OS will be assessed. The ability to predict PET score (PET1 and PET2) and Hodgkin lymphoma events within 3 years will be compared: 8A Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PFS; 8B Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and OS; 8C Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and EFS; 8D Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PET1 DS; 8E Associations between baseline quantitative PET parameters such as total lesion glycolysis (TLG) and PET2 DS

Time frame
Up to 3 years after end of treatment
3

Change in pulmonary function tests at end of treatment, 1 and 2 years

Change from baseline pulmonary function test (DLCO/TLCO percentage of normal) will be compared

Time frame
3 months & 1 year after end of treatment
4

Correlation between maximum tumour dimension at baseline and end of treatment with PFS

The relationship between maximum tumour dimension at baseline and at end of treatment and PFS will be examined. This may also be analysed within the groups that achieve/do not achieve CMR after 2 cycles and may also be adjusted for the use of consolidation radiotherapy

Time frame
Up to 5 years after end of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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