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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Ulatzxjnbb Hoftawvr Clnvjfu Cologne Germany
Umggrpmdwpbkpsteyxlnc Hbyflzxxwj Asg Heidelberg Germany
Elwrko Gtadcrkdelba feis ededgfotzlnjjjql uvn knxmbocat Fddmakuzq iv djg Mbwaxsr mix Berlin Germany
Uanoacxohr Mnlmxdg Chknnj Hhloyhtnhpugjfhyc Hamburg Germany
Uycfvoxxkugkzzghkzdrw Ewwoz Arr Essen Germany
Gkqmrshjqh Nmdm gxqxt Kpxohqvmxcnac Bqjzcv Bremen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
04.01.2027

Trial locations

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.

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 ID:
2025-521749-26-00
Protocol code:
Uni-Koeln-5576
NCT ID:
NCT06919679
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study of nivolumab plus drug combination versus standard first-line therapy in patients with advanced Hodgkin lymphoma

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Poland
  • A Study of Pembrolizumab and Radiotherapy for Patients with Early-Stage Favorable Classic Hodgkin Lymphoma

    Recruiting

    2 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Germany