Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Atezolizumab and Drug Combination for Patients with Relapsed or Refractory Hodgkin's Lymphoma Eligible for Stem Cell Transplant

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a type of cancer called Hodgkin's lymphoma, which affects the lymphatic system, a part of the immune system. The study is testing a combination of treatments to see how effective they are for patients whose disease has returned or did not respond to initial treatments. The treatments being studied include atezolizumab, a type of medication known as a monoclonal antibody, and a combination of drugs known as the BEGEV regimen. The BEGEV regimen includes the drugs bendamustine hydrochloride, gemcitabine, vinorelbine, and vinorelbine tartrate. These medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best dose of atezolizumab when used with the BEGEV regimen and to see how well this combination works before patients undergo a procedure called autologous stem-cell transplantation. This procedure involves using a patient's own stem cells to help restore their bone marrow after intensive treatment. The study is divided into two phases. In the first phase, researchers will determine the safest and most effective dose of atezolizumab. In the second phase, they will assess how well the treatment works in reducing the cancer before the stem-cell transplantation.

Participants in the study will receive the treatment over several cycles, with regular assessments to monitor their response to the therapy. The study aims to provide valuable information on the effectiveness and safety of this treatment combination for patients with relapsed or refractory Hodgkin's lymphoma. The results will help guide future treatment options for this condition.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, previous treatments, and health status.

    The study is designed for patients with relapsed or refractory Hodgkin's lymphoma who are candidates for stem-cell transplantation.

  2. Step 2

    Phase I treatment

    The initial phase aims to determine the maximum tolerated dose of atezolizumab in combination with the BEGEV regimen.

    The BEGEV regimen includes bendamustine hydrochloride, vinorelbine, and gemcitabine, all administered through intravenous infusion.

    This phase involves monitoring for any severe side effects during the first 21 days of treatment.

  3. Step 3

    Phase IIb treatment

    In this phase, the effectiveness of the treatment is assessed after four cycles of the induction treatment.

    The response to treatment is evaluated using specific criteria to determine the complete response rate before stem-cell transplantation.

  4. Step 4

    Monitoring and assessment

    Throughout the study, regular assessments are conducted to monitor the patient's response to treatment and any adverse effects.

    These assessments include imaging tests and blood tests to evaluate the disease status and overall health.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment cycles, the patient's response is thoroughly evaluated.

    The study aims to determine the duration of response and progression-free survival, which measures the time until the disease progresses or relapses.

Who can join the trial?

8 criteria

  • Must be between 18 and 60 years old (the upper age limit is only for phase I).
  • Must have a confirmed diagnosis of **Hodgkin's lymphoma**. This means the disease has either come back after treatment or did not respond to the first treatment. The first treatment could have been one of several specific drug combinations.
  • Must have had only one previous treatment for **Hodgkin's lymphoma**.
  • Must be eligible for **ASCT**, which stands for autologous stem cell transplant, a procedure that uses the patient's own stem cells.
  • Must have a **performance status** of 2 or less on the **ECOG scale**. This scale measures how well a person can perform daily activities, with lower numbers indicating better ability.
  • Must have adequate **blood function**, unless the lymphoma affects the bone marrow. This means having enough **neutrophils** (a type of white blood cell), **platelets** (cells that help with blood clotting), and **hemoglobin** (a protein in red blood cells) without needing blood transfusions.
  • Must be able and willing to follow the study visit schedule and procedures.
  • Must agree to use effective birth control without interruption, starting 28 days before treatment and continuing for at least 6 months after treatment ends. Participants must also agree not to donate semen or eggs during treatment and for at least 6 months after the last treatment dose.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than Hodgkin's lymphoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have any medical condition that the study doctors think might make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are recovering from one.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the immune system attack cancer cells. It is a type of immunotherapy that works by blocking a protein that prevents the immune system from effectively fighting cancer. In this study, it is combined with other treatments to see if it can improve outcomes for patients with Hodgkin's lymphoma.

  • BEGEV regimen

    is a combination of chemotherapy drugs used to treat Hodgkin's lymphoma. This regimen includes several medications that work together to kill cancer cells or stop them from growing. The BEGEV regimen is used as a first salvage treatment, which means it is given to patients whose cancer has returned or not responded to previous treatments.

What is already known about the treatment

Atezolizumab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Hodgkin's lymphoma, particularly in patients who have relapsed or are refractory to other treatments. Atezolizumab is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, which can help the immune system recognize and attack cancer cells more effectively. It is classified as a monoclonal antibody and is being evaluated in combination with the BEGEV regimen to determine its maximum tolerated dose and overall response rate before autologous stem-cell transplantation.

Investigated diseases

Hodgkin's Lymphoma – Hodgkin's lymphoma is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease typically begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms often include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it may affect the body's ability to fight infections. Hodgkin's lymphoma is generally considered a rare disease but is one of the most treatable forms of cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511631-10-00Estimated enrolment140 patientsSponsorFondazione Italiana Linfomi Ets

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.