Brentuximab vedotin for early stage Hodgkin lymphoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of brentuximab vedotin in combination with standard chemotherapy for patients with early-stage Hodgkin lymphoma. Participants will be randomly assigned to receive either the traditional ABVD chemotherapy or the A2VD regimen, which includes brentuximab vedotin. An interim PET-CT scan will be conducted after two cycles of treatment to assess response and adapt further therapy accordingly. The trial aims to improve treatment outcomes by personalizing therapy based on PET scan results.

Why it matters

Who can join: the full rules

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 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

Exclusion Criteria:

* 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

Where it's running

• Stanford University - (Stanford Cancer Institute)
  Stanford, California, United States Recruiting
• University of Miami School of Medicine
  Miami, Florida, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Royal North Shore Hospital
  Saint Leonards, New South Wales, Australia Recruiting
• Townsville University Hospital
  Townsville, Queensland, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, Australia Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: John Radford — University of Manchester / Christie Hospital, Manchester
• Study coordinator: RADAR Trial Coordinator
• Email: ctc.radar@ucl.ac.uk
• Phone: +44(0)207 679 9860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New treatment approach for relapsed or refractory Hodgkin lymphoma

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• Survey of Brentuximab Vedotin for treating pediatric Hodgkin Lymphoma

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  This study is testing if new drugs Pembrolizumab and Brentuximab vedotin work better than standard treatment for people with relapsed Hodgkin lymphoma.

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• New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.