Actively Recruiting
A Randomised Phase III Trial Comparing ABVD - Involved Site Radiotherapy With A2VD - Involved Site Radiotherapy in Patients With Untreated Stage IAIIA Hodgkin Lymphoma
Led by University College, London · Updated on 2026-06-02
1042
Participants Needed
71
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
T
Takeda
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an international, randomized phase III trial called RADAR to compare two chemotherapy regimens, ABVD and A2VD, in patients with early-stage Hodgkin lymphoma. This study aims to evaluate how well these treatments work and adapt therapy based on PET-CT scan results after two cycles. The trial is led by University College London and the Canadian Cancer Trials Group, combining data from Europe, AustraliaNew Zealand, and North America to achieve the total sample size. Participants will be randomly assigned to receive either ABVD chemotherapy doxorubicin, bleomycin, vinblastine, and dacarbazine or A2VD chemotherapy doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support. After two cycles, a PET-CT scan will guide further treatment patients with favorable scan results will receive one more chemotherapy cycle those with less favorable results will receive two more cycles plus involved site radiotherapy and those with the least favorable results will stop trial treatment and receive other care as decided by their doctor. Some patients may also have an additional PET-CT scan to confirm treatment response. During the study, participants will have PET-CT scans to monitor disease response, and researchers will follow them for at least five years after treatment ends. The main outcome measured is progression-free survival at three years, with additional assessments including event-free survival, overall survival, safety, toxicity, and incidence of second cancers or cardiovascular disease. Patients will be closely monitored for side effects and treatment response throughout the trial.
CONDITIONS
Brief Title
Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 16 to 69 years (inclusive) (age range is 18-69 in US and EU)
- Histologically confirmed classical Hodgkin lymphoma
- Stage I or II supradiaphragmatic disease without mediastinal bulk disease or B symptoms
- Bulky disease at other sites and certain extranodal disease are acceptable
- ECOG performance status 0-2
- No previous treatment for Hodgkin lymphoma
- Fit to receive anthracycline-based chemotherapy
- Creatinine clearance greater than 40ml/min
- Total bilirubin less than 1.5 times upper limit of normal unless due to disease or Gilbert's syndrome
- ALT or AST less than 2 times upper limit of normal
- Adequate bone marrow function with neutrophils at least 1.0x10^9/l and platelets at least 100x10^9/l
- Hemoglobin at least 8 g/dL
- Willing and able to comply with protocol requirements including contraceptive advice
- Written informed consent
You will not qualify if you...
- Previous treatment for Hodgkin lymphoma except short courses of oral corticosteroids
- Infradiaphragmatic disease
- Nodular lymphocyte predominant Hodgkin lymphoma
- No FDG-avid lesions on baseline PET scan
- Age under 16 or over 69 years
- Other cancer diagnosed in the last 5 years except certain skin cancers and excised carcinoma in situ
- Recurrent or persistent other cancer within last 5 years
- Pre-existing grade 1 or higher sensory or motor neuropathy
- History of or current progressive multifocal leukoencephalopathy or other chronic brain conditions
- Symptomatic neurologic disease affecting daily living or requiring medication
- Infection with HIV, hepatitis C, or active hepatitis B
- Active systemic infection requiring antibiotics, antivirals, or antifungals within 2 weeks before trial
- Receiving or recently treated with other investigational agents within 4 weeks prior to trial
- Pregnant or breastfeeding women
- Known hypersensitivity to components of brentuximab vedotin or ABVD
- Known cardiovascular or respiratory conditions preventing use of anthracycline or bleomycin
- Other significant medical or psychiatric conditions making trial treatment hazardous
Research Team
R
RADAR Trial Coordinator
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