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Phase III Trial Comparing ABVD vs A2VD Treatment With PET-Guided Radiation Therapy for Patients With Early Stage Hodgkin Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying stage IA/IIA Hodgkin lymphoma, a type of blood cancer affecting the lymphatic system. The study compares two chemotherapy regimens: the standard ABVD (a combination of doxorubicin, bleomycin, vinblastine, and dacarbazine) versus A2VD (which modifies the standard regimen). Both treatments may be combined with ISRT (involved-site radiation therapy). The trial uses a PET-response adapted design, meaning that treatment decisions are guided by results from PET scans (a type of imaging that shows how tissues are functioning) after initial cycles of chemotherapy.

The purpose of this research is to determine if the modified chemotherapy regimen (A2VD) can improve how long patients remain free from disease progression compared to the standard treatment. Patients will receive either ABVD or A2VD chemotherapy, and depending on their response as shown on PET scans after two treatment cycles, they may continue with the same treatment or receive additional radiation therapy.

This study is designed for patients with early-stage Hodgkin lymphoma who have not received previous treatment for their disease. The study will monitor patients for treatment effectiveness, side effects, and long-term outcomes including the development of second cancers and heart disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide written consent to participate.

    You will undergo initial assessments to confirm eligibility, including blood tests and imaging scans.

  2. Step 2

    Treatment phase 1

    You will begin the first phase of treatment, which involves receiving a combination of medications. These medications are administered through an intravenous (IV) line, which means they are given directly into your bloodstream.

    The medications include vinblastine sulfate, dacarbazine, bleomycin, and doxorubicin hydrochloride. The specific dosages and frequency will be determined by your healthcare team.

  3. Step 3

    PET scan assessment

    After completing two cycles of the initial treatment, you will undergo a PET scan. This scan helps assess how well the treatment is working by checking for changes in the activity of the lymphoma.

    Based on the results of the PET scan, your treatment plan may be adjusted.

  4. Step 4

    Treatment phase 2

    Depending on the PET scan results, you may continue with the same treatment or switch to a different combination of medications. This may include brentuximab vedotin and filgrastim, which is given subcutaneously (under the skin).

    The treatment will continue for a specified duration, with regular monitoring and assessments.

  5. Step 5

    Follow-up and monitoring

    Throughout the trial, you will have regular follow-up appointments to monitor your health and the effectiveness of the treatment.

    These appointments may include physical exams, blood tests, and imaging scans to ensure the treatment is working and to check for any side effects.

  6. Step 6

    End of trial

    At the end of the trial, you will have a final assessment to evaluate the overall outcome of the treatment.

    You will receive information about any further treatment or follow-up care that may be necessary.

Who can join the trial?

13 criteria

  • Men and women aged 16 to 69 years. For some centers, the age range is 18 to 69 years.
  • Must have adequate bone marrow function, which means having enough healthy blood cells. Specifically, neutrophils (a type of white blood cell) should be at least 1.0 x 109/l and platelets (cells that help with blood clotting) should be at least 100 x 109/l.
  • Hemoglobin (a protein in red blood cells that carries oxygen) should be at least 8g/dl.
  • Must be willing and able to follow the study requirements, including advice on birth control if needed.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must have a confirmed diagnosis of classical Hodgkin lymphoma through a tissue sample examination.
  • Must have stage I or II disease located above the diaphragm (the muscle that helps with breathing) without large tumors in the chest area. Large tumors are defined as greater than a third of the chest width at any level of the thoracic spine as seen on a CT scan. Large tumors in other areas are acceptable. Disease that has spread to one nearby area outside the lymph nodes is also acceptable.
  • Must have an ECOG performance status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
  • Must not have received any previous treatment for Hodgkin lymphoma.
  • Must be fit to receive anthracycline-based chemotherapy, a type of cancer treatment. If there is a history of heart disease or high blood pressure, the heart's pumping ability should be at least 50%.
  • Creatinine clearance (a measure of kidney function) should be more than 40 ml/min.
  • Total bilirubin (a substance made by the liver) should be less than 1.5 times the upper limit of normal, unless it is due to the disease or a known condition called Gilbert’s syndrome.
  • ALT or AST (enzymes that indicate liver health) should be less than 2 times the upper limit of normal.

Who cannot join the trial?

7 criteria

  • Patients with a different type of cancer than stage IA/IIA Hodgkin lymphoma cannot participate. This is a specific type of cancer affecting the lymphatic system.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding may not be eligible to participate, as the study may involve treatments that could affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible, as this could affect the study results.
  • Patients with certain medical conditions that could interfere with the study or make participation unsafe may be excluded.
  • Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, may not be eligible.
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Investigated drugs

  • ABVD

    is a combination of four different drugs used to treat Hodgkin lymphoma. These drugs work together to stop cancer cells from growing and dividing. The combination includes a medicine that damages the DNA of cancer cells, a medicine that interferes with the growth of cancer cells, a medicine that stops cancer cells from making proteins they need to grow, and a medicine that helps the immune system fight cancer.

  • A2VD

    is another combination of drugs used in the treatment of Hodgkin lymphoma. This combination is being studied to see if it can improve outcomes for patients compared to the traditional ABVD treatment. Like ABVD, A2VD works by targeting cancer cells in different ways to stop them from growing and spreading.

  • ISRT

    stands for involved-site radiation therapy. This therapy uses high-energy rays to target and kill cancer cells in specific areas of the body where the cancer is located. ISRT is often used in combination with chemotherapy to help improve the chances of eliminating the cancer.

What is already known about the treatment

  • ABVD

    ABVD is a chemotherapy regimen administered intravenously, meaning it is given through a vein. It is currently well-established in medical practice and literature for treating Hodgkin lymphoma, particularly in early stages like IA and IIA. The main therapeutic indication for ABVD is to treat Hodgkin lymphoma by stopping the growth of cancer cells. At the molecular level, it works by interfering with the DNA of cancer cells, preventing them from dividing and growing. ABVD is classified pharmacologically as a combination chemotherapy regimen.

  • A2VD

    A2VD is a newer chemotherapy regimen also administered intravenously, designed to treat Hodgkin lymphoma, specifically in early stages such as IA and IIA. It is being studied in clinical trials to determine if it can improve progression-free survival compared to the traditional ABVD regimen. A2VD works at the molecular level by targeting and disrupting the DNA of cancer cells, thereby inhibiting their ability to multiply. It is classified as a combination chemotherapy regimen, similar to ABVD, but with a different composition of drugs.

Investigated diseases

Stage IA/IIA Hodgkin Lymphoma – Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. In stage IA, the cancer is found in a single lymph node region or a single organ. In stage IIA, the cancer is in two or more lymph node regions on the same side of the diaphragm, which is the muscle under the lungs that helps with breathing. The disease progresses by spreading to nearby lymph nodes and potentially to other parts of the body. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500031-37-00Protocol code​​ UCL/15/0105Estimated enrolment631 patientsSponsorUniversity College London

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