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Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
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.
Study details:
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 * Patients with Deauville score 5 will be withdrawn from trial treatment.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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 16 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-04-14
Primary completion: 2030-09-01
Study completion finish: 2032-09-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT04685616
Intervention or treatment
RADIATION: Involved site radiotherapy
DRUG: Doxorubicin
DRUG: Bleomycin
DRUG: Brentuximab vedotin
DRUG: Vinblastine
DRUG: Dacarbazine
DRUG: Haematopoietic growth factor
Conditions
- • Hodgkin Lymphoma
Find a site
Closest Location:
Royal North Shore Hospital
Research sites nearby
Select from list below to view details:
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Townsville University Hospital
Townsville, Queensland, Australia
Royal Adelaide Hospital
Adelaide, Not Specified, Australia
Box Hill Hospital
Box Hill, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: ABVD +/- ISRT
| RADIATION: Involved site radiotherapy
|
EXPERIMENTAL: A2VD +/- ISRT
| RADIATION: Involved site radiotherapy
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Progression free survival (PFS) | Time from randomisation to first date of progression or death | 3 years from end of treatment |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| PET-CMR (complete metabolic response) rate | Proportion of patients who have Deauville score 1-3 on PET-CT scan | At the end of cycle 2 (each cycle is 28 days) |
| Event-free survival (EFS) | Time from randomisation to first date of progression, death or a positive PET2 scan (whichever occurs first) | 5 years from end of treatment |
| Overall survival (OS) | Time from randomisation to death | 5 years from end of treatment |
| Incidence of second cancers and cardiovascular disease | Proportion in each arm who develop a second cancer or cardiovascular disease | 5 years from end of treatment |
| Safety and toxicity of ABVD and A2VD as described by CTCAE v5.0 | Numbers of patients experiencing a grade 3+ adverse event of each type will be presented and compared between the arms. Only patients who start treatment will be included | From start of treatment to 30 days post treatment |
Frequently Asked Questions
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