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Brentuximab vedotin for early stage Hodgkin lymphoma treatment

A Randomised Phase III Trial With a PET Response Adapted Design Comparing ABVD +/- ISRT With A2VD +/- ISRT in Patients With Previously Untreated Stage IA/IIA Hodgkin Lymphoma

PHASE3 · University College, London · NCT04685616

This study is testing if adding a new drug called brentuximab vedotin to standard chemotherapy can help people with early-stage Hodgkin lymphoma do better in their treatment.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1042 (estimated)
Ages16 Years to 69 Years
SexAll
SponsorUniversity College, London (other)
Drugs / interventionsbrentuximab, chemotherapy, doxorubicin
Locations70 sites (Stanford, California and 69 other locations)
Trial IDNCT04685616 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 16-69 with histologically confirmed classical Hodgkin lymphoma at stage I or II without mediastinal bulk disease.

Not a fit: Patients with previous treatment for Hodgkin lymphoma or those with significant comorbidities affecting their ability to receive chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tailored treatment options for patients with early-stage Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar PET-response adapted approaches in Hodgkin lymphoma treatment, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 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 this trial is running

Stanford, California and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hodgkin Lymphoma, PET-response adapted, Stage IA/IIA Hodgkin lymphoma, Brentuximab vedotin

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.