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New treatment option for Hodgkin Lymphoma
Official title Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT04685616
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, being studied as a potential treatment for hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 69
You may be able to join if
- 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...
- ECOG performance status 0-2.
- No previous treatment for Hodgkin lymphoma
You likely can't join if
- Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg prednisolone (or equivalent) for up to 7...
- Infradiaphragmatic disease
- Nodular lymphocyte predominant Hodgkin lymphoma
- Absence of FDG-avid lesions on baseline PET scan
- Age 70 years or over or age 15 years or under
- Other cancer diagnosed with the last 5 years. Patients with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of...
See the full eligibility 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...
- 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 marrow function with neutrophils ≥1.0x10\^9/l and platelets ≥100x10\^9/l
- Haemoglobin ≥8g/dL
- Willing and able to comply with the requirements of the protocol, including contraceptive advice, where applicable
- Written informed consent
- Previous treatment for Hodgkin lymphoma, excluding short courses of oral corticosteroids at a dose of 100mg prednisolone (or equivalent) for up to 7 days
- Infradiaphragmatic disease
- Nodular lymphocyte predominant Hodgkin lymphoma
- Absence of FDG-avid lesions on baseline PET scan
- Age 70 years or over or age 15 years or under
- Other cancer diagnosed with the last 5 years. Patients with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin are not excluded
- Recurrent or persistent other cancer within last 5 years irrespective of date of initial diagnosis
- Pre-existing grade ≥1 sensory or motor neuropathy from any cause
- History of or current progressive multi-focal leukoencephalopathy or other chronic condition of the brain
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
- Infection with HIV, hepatitis C or active hepatitis B infection (surface antigen or DNA positive)
- Any active systemic viral, bacterial or fungal infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first trial drug dose
- Receiving or recently treated with any other investigational agent (within 4 weeks of trial entry)
- Pregnant or breastfeeding women
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of ABVD
- Known history of any cardiovascular or respiratory conditions that would preclude anthracycline or bleomycin administration
- Other significant medical or psychiatric comorbidity that in the opinion of the investigator would make administration of ABVD or A2VD hazardous
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Miami, Florida, United States
- New York, New York, United States
- Saint Leonards, New South Wales, Australia
- Townsville, Queensland, Australia
- Adelaide, Australia
- Box Hill, Australia
- Brisbane, Australia
- Darwin, Australia
- Liverpool, Australia
- Melbourne, Australia
- Sydney, Australia
- Roeselare, West Flanders, Belgium
- Antwerp, Belgium
- Leuven, Belgium
- Namur, Belgium
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Ottawa, Canada
- Saint John, Canada
+ 46 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Miami, Florida, United States; New York, New York, United States; Saint Leonards, New South Wales, Australia; Townsville, Queensland, Australia; Adelaide, Australia and 60 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.