Brentuximab Vedotin in Early Stage Hodgkin Lymphoma

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

Interventions

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

Sponsors & Collaborators

• Takeda

  collaborator INDUSTRY

• University of Miami

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• Australasian Leukaemia and Lymphoma Group

  collaborator OTHER

• Seagen Inc.

  collaborator INDUSTRY

• Canadian Cancer Trials Group

  collaborator NETWORK

• University College, London

  lead OTHER

Principal Investigators

• John Radford · University of Manchester / Christie Hospital, Manchester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-14

Primary Completion

2030-09-30

Completion

2032-09-30

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Canada
• Denmark
• Ireland
• Netherlands
• New Zealand
• Portugal
• Slovakia
• Spain
• United Kingdom

Study Locations