Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma.
Nina Kreuzberger, Marius Goldkuhle, Bastian von Tresckow...
https://pubmed.ncbi.nlm.nih.gov/40135712/Actively Recruiting
Led by University College, London · Updated on 2026-07-08
1042
Participants Needed
72
Research Sites
104 weeks
Total Duration
This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. 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 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.
CONDITIONS
Brentuximab Vedotin in Early Stage Hodgkin Lymphoma
R
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University College, London
Lead Sponsor
Takeda
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | A2VD (Brentuximab Vedotin, Doxorubicin, Vinblastine, Dacarbazine) +/- Involved Site Radiotherapy | ABVD (Doxorubicin, Bleomycin, Vinblastine, Dacarbazine) +/- Involved Site Radiotherapy | PET-guided ABVD +/- Involved Site Radiotherapy |
|---|---|---|---|
| What it is | Investigational chemotherapy regimen replacing bleomycin with Brentuximab vedotin, alongside doxorubicin, vinblastine, and dacarbazine, with or without involved site radiotherapy, as tested in the trial. | Standard chemotherapy regimen combining doxorubicin, bleomycin, vinblastine, and dacarbazine, with or without involved site radiotherapy (ISRT), per current conventional protocols. | Guideline-recommended approach using ABVD, with treatment adapted based on mid-treatment PET/CT response, followed by involved site radiotherapy only if indicated. This PET-adapted strategy is standard for early-stage Hodgkin lymphoma. |
| Role in the trial | Experimental arm; participants receive A2VD (Brentuximab vedotin replaces bleomycin) +/- ISRT. | Active comparator arm; participants receive conventional ABVD +/- ISRT. | Standard treatment outside this trial, used to benchmark trial findings against current practice. |
| Primary use | Aims to improve efficacy and minimize toxicity, especially pulmonary toxicity, by substituting Brentuximab vedotin for bleomycin in the ABVD backbone +/- radiotherapy. | Aims to achieve remission and prevent relapse in early-stage classical Hodgkin lymphoma through established multi-agent chemotherapy +/- radiotherapy. | PET-adapted ABVD is used to maximize cure rates while limiting overtreatment, using early PET response to guide further ABVD cycles or radiotherapy. |
| How it is given or performed | Chemotherapy cycles substitute Brentuximab vedotin for bleomycin; other drugs and radiotherapy are given as in ABVD arm. Radiotherapy dosing as per ILROG guidelines. | Chemotherapy is given in cycles (typically 28 days), with intravenous infusions of each drug. Radiotherapy is applied to involved sites as per ILROG guidance depending on disease factors. | Chemotherapy delivery mirrors standard ABVD cycles. PET/CT performed after initial cycles; further ABVD or radiotherapy decisions depend on metabolic response. |
| Evidence status | A2VD +/- ISRT is under investigation for whether Brentuximab vedotin can preserve efficacy while reducing toxicity compared to ABVD. Published evidence supports Brentuximab vedotin in advanced disease; early-stage role is being established. | ABVD +/- ISRT is supported by decades of research and is the reference standard for early-stage classical Hodgkin lymphoma. Long-term cure rates exceed 90% in non-bulky, early-stage disease. | PET-guided ABVD +/- ISRT achieves high cure rates with reduced late toxicity by personalizing treatment based on early response. Supported by systematic review and guideline consensus. |
| Important limitations | Clinical benefits, long-term toxicity, and safety profile of substituting Brentuximab vedotin for bleomycin in early-stage disease remain unproven until trial results mature. Cost and late effects are not yet established. | Bleomycin is associated with risk of pulmonary toxicity; the regimen may lead to late cardiovascular and secondary cancer risk. Optimal radiotherapy dose and fields remain debated. | PET-guided ABVD may miss rare cases of false negative PET, leading to under-treatment. Debate exists regarding the best response threshold and radiotherapy indications. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 to 4 cycles of chemotherapy over approximately 12 to 16 weeks
Participants receive randomized chemotherapy with either ABVD or A2VD. After two cycles, a PET-CT scan is performed to guide further treatment. Based on scan results, participants may receive additional chemotherapy cycles and/or involved site radiotherapy or discontinue trial treatment if disease progresses.
PET-CT scan after 2 cycles; additional scans if indicated
Duration - At least 5 years
Participants are followed for a minimum of 5 years after completing treatment to monitor health outcomes including progression-free survival, event-free survival, overall survival, and any late side effects.
Regular follow-up visits as per protocol
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nina Kreuzberger, Marius Goldkuhle, Bastian von Tresckow...
https://pubmed.ncbi.nlm.nih.gov/40135712/University College, London
Lead Sponsor
Takeda
Collaborating Sponsor