NCT04685616

Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +/- ISRT With A2VD +/- ISRT in Patients With Previously Untreated Stage IA/IIA Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,042 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
RADIATION	Involved site radiotherapy	Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines. Recommended dose 30Gy
DRUG	Doxorubicin	See arm description
DRUG	Bleomycin	See arm description
DRUG	Brentuximab vedotin	See arm description
DRUG	Vinblastine	See arm description
DRUG	Dacarbazine	See arm description
DRUG	Haematopoietic growth factor	See arm description

Timeline

• Start date: 2022-04-14
• Primary completion: 2030-09-01
• Completion: 2032-09-01
• First posted: 2020-12-28
• Last updated: 2026-03-30

Locations

70 sites across 12 countries: United States, Australia, Belgium, Canada, Denmark, Ireland, Netherlands, New Zealand, Portugal, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study