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Phase II Study of Brentuximab Vedotin with Drug Combination in HIV‑Positive Patients with Advanced‑Stage Classic Hodgkin Lymphoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The trial focuses on people who have Advanced Stage Classic Hodgkin Lymphoma and are HIV-positive. The chemotherapy regimen, called BrECADD, combines several medicines given by IV infusion: doxorubicin hydrochloride, dacarbazine citrate, etoposide, cyclophosphamide, and the antibody‑drug conjugate brentuximab vedotin. An oral steroid, dexamethasone, is also taken to help reduce side effects.

The purpose of the study is to determine whether a treatment plan guided by PET scans and consisting of 4 to 6 cycles of BrECADD can be given safely to this group, as measured by TRMB. PET is a special imaging test that shows active disease. TRMB refers to serious side effects, such as organ damage or infections, that are graded using the CTCAE system.

Participants receive the drug infusion every few weeks for a total of 4 to 6 cycles, with a PET scan after the second cycle to see how the disease is responding. If the scan shows a good response, treatment continues; otherwise the plan may be adjusted. After the last dose, patients are followed for up to two years to track the rate of complete remission (CR), how long they stay free of disease (PFS), overall survival (OS), quality of life, and immune health measured by CD4 counts.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment and first chemotherapy cycle

    After joining the study, you will have baseline examinations that may include blood tests, imaging, and a pet scan to document the extent of disease.

    On the same day, you will receive the first chemotherapy cycle. the infusion includes:

    brentuximab vedotin 1.8 mg per kilogram of body weight, given by intravenous infusion;

    cyclophosphamide 1250 mg per square meter of body surface area, given by intravenous infusion;

    doxorubicin hydrochloride 40 mg per square meter, given by intravenous infusion;

    etoposide 150 mg per square meter, given by intravenous infusion;

    dacarbazine citrate 250 mg, given by intravenous infusion;

    In addition, you will take dexamethasone 40 mg by mouth on the day of infusion.

  2. Step 2

    Evaluation after each cycle

    After completing a cycle, you will undergo a pet scan, which is an imaging test that shows how the cancer is responding to treatment.

    The results of the pet scan are used to decide whether you will continue with additional cycles.

  3. Step 3

    Subsequent chemotherapy cycles

    If the pet scan indicates that the disease is still active, you will receive another chemotherapy cycle with the same drugs and doses listed in step 1.

    The schedule repeats every few weeks as directed by the study protocol.

    You will continue to have a pet scan after each cycle to guide further treatment.

  4. Step 4

    Completion of treatment

    Treatment stops after a minimum of four cycles and may continue up to a maximum of six cycles, depending on the pet scan results.

    Once the final cycle is finished, you will have a final pet scan and additional assessments to determine whether a complete remission has been achieved.

  5. Step 5

    Post‑treatment follow‑up

    After treatment ends, you will be monitored for side effects and for any signs that the disease may return.

    Follow‑up visits may include blood tests, imaging, and questionnaires about your quality of life.

Who can join the trial?

5 criteria

  • Histologically confirmed first diagnosis of classic Hodgkin lymphoma – a tissue sample has been examined under a microscope to prove this is the first time you have this cancer.
  • Advanced‑stage disease: you must have either stage IIB with a large mass in the chest area (mediastinal mass) and/or cancer that has spread outside the lymph nodes (extranodal lesions), or be in stage III or IV, which means the disease has spread further.
  • Age between 18 and 75 years at the time you join the study.
  • Confirmed HIV infection with CD4 count ≥ 50 cells per microliter – a blood test showing you have HIV and a CD4 level (a type of immune cell) of at least 50.
  • You must be taking antiretroviral treatment (ART) or, if you have never taken it before (ART‑naïve), you must start ART as part of the study requirements.

Who cannot join the trial?

6 criteria

  • People who have other types of lymphoma such as Nodular lymphocyte‑predominant Hodgkin lymphoma, composite lymphoma, grey‑zone lymphoma, or lymphoma that has spread to the central nervous system (the brain or spinal cord) cannot join.
  • Anyone who has already received treatment specifically for classic Hodgkin lymphoma, except only a short course of a steroid medicine (corticosteroid) or a drug called cyclophosphamide before the main treatment, is excluded.
  • People who have previously had chemotherapy (medicine that kills cancer cells), radiotherapy (high‑energy radiation to kill cancer cells), or a stem cell transplant using a donor (allogeneic) or a solid organ transplant (such as a kidney or liver) cannot participate.
  • Those with multi‑drug‑resistant HIV infection (HIV that does not respond to several medicines) or who currently have illnesses that are considered AIDS‑defining conditions (serious infections or cancers that show AIDS) are not eligible.
  • Anyone who has other medical illnesses now or in the past that would make it unsafe to receive the study treatment is excluded.
  • Women who are pregnant or breastfeeding cannot be in the trial.
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Investigated drugs

  • Doxorubicin

    is a chemotherapy drug that stops cancer cells from growing and dividing. In this study it is given by intravenous infusion as part of the combination regimen to treat Hodgkin lymphoma.

  • Dacarbazine

    is a chemotherapy medicine that interferes with the DNA of cancer cells, helping to stop them from multiplying. It is administered through an IV as one of the drugs in the treatment plan.

  • Etoposide

    is a chemotherapy agent that damages the DNA of cancer cells, which leads to cell death. It is given by intravenous infusion in the trial.

  • Dexamethasone

    is a steroid that reduces inflammation and helps control side effects of chemotherapy, such as nausea and allergic reactions. In this trial it is taken orally.

  • Brentuximab vedotin

    (brand name ADCETRIS) is a targeted therapy that attaches to a protein found on Hodgkin lymphoma cells and delivers a chemotherapy drug directly to them. It is given by intravenous infusion and is a key part of the BrECADD regimen.

  • Cyclophosphamide

    is a chemotherapy drug that interferes with the DNA of cancer cells, preventing them from growing. It is administered intravenously as part of the combination therapy.

What is already known about the treatment

  • Doxorubicin

    This drug is given by slow intravenous infusion into a vein. It is an approved chemotherapy medicine that has been used for many years in cancer treatment. It is mainly used for Hodgkin lymphoma and other solid tumors. It works by slipping between DNA strands and stopping the cells from copying their genetic material, and it belongs to the anthracycline antibiotic class.

  • Dacarbazine

    Dacarbazine is administered by intravenous infusion. It is a well‑established chemotherapy agent that is listed in medical guidelines worldwide. It is used for Hodgkin lymphoma and some skin and soft‑tissue cancers. It acts by changing the DNA inside cancer cells so they cannot grow, and it is classified as an alkylating agent.

  • Etoposide

    Etoposide is given as an intravenous infusion. It is a standard chemotherapy drug that has been approved for decades. It is used to treat Hodgkin lymphoma, lung cancer and other solid tumors. It works by blocking an enzyme that helps cancer cells unwind DNA, and it belongs to the topoisomerase inhibitor class.

  • Dexamethasone

    Dexamethasone is taken orally as a tablet. It is an approved corticosteroid that is widely used in many medical conditions. It is used in cancer therapy to reduce inflammation, prevent allergic reactions, and help control nausea. It works by mimicking natural hormones that suppress the immune response, and it is classified as a glucocorticoid steroid.

  • Brentuximab vedotin

    Brentuximab vedotin comes as a powder that is mixed with liquid and given by intravenous infusion. It is an FDA‑approved antibody‑drug conjugate used in modern cancer care. It is indicated for Hodgkin lymphoma and certain other CD30‑positive lymphomas. It combines an antibody that finds cancer cells with a chemotherapy payload that destroys them, and it is classified as an antibody‑drug conjugate.

  • Cyclophosphamide

    Cyclophosphamide is delivered by intravenous infusion. It is a long‑standing chemotherapy drug that is included in many treatment protocols worldwide. It is used for Hodgkin lymphoma, breast cancer, and several other cancers. It works by adding chemical groups to DNA, which stops cells from dividing, and it belongs to the alkylating (nitrogen mustard) class.

Investigated diseases

Advanced Stage Classic Hodgkin Lymphoma - Classic Hodgkin lymphoma is a cancer of the lymphatic system that begins in lymph nodes. In the advanced stage, the disease has spread beyond the original site to additional lymph node groups or other organs. It often appears as painless swelling of lymph nodes, sometimes accompanied by fever, night sweats, or weight loss. The malignant cells multiply and can invade surrounding tissues, forming larger masses. As the disease progresses, multiple regions of the body can become involved.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521749-26-00Protocol codeUni-Koeln-5576Estimated enrolment35 patientsSponsorUniversity Of Cologne

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