NCT04685616 Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
| NCT ID | NCT04685616 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University College, London |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,042 participants |
| Start Date | 2022-04-14 |
| Primary Completion | 2030-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. * No previous treatment for Hodgkin lymphoma * Fit to receive anthracycline-based chemotherapy (patients with a history of ischaemic heart disease or hypertension should have a left ventricular ejection fraction of ≥50%) * Creatinine clearance (measured or calculated \>40ml/min * Total bilirubin \<1.5 x upper limit of normal, unless attributable to disease or known Gilbert's syndrome * ALT or AST \< 2 x upper limit of normal * Adequate bone marr