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Study of Nivolumab and Chemotherapy Combination for Patients with Refractory Hodgkin's 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 focused on studying a type of cancer called Hodgkin's lymphoma, specifically in patients whose disease has not responded to initial treatment. The study will use a medication called nivolumab, which is given through an infusion into a vein. Nivolumab is a type of treatment that helps the immune system fight cancer cells. After receiving nivolumab, patients will undergo chemotherapy with three drugs: bendamustine, gemcitabine, and dexamethasone. This will be followed by a procedure called autologous bone marrow transplantation, where a patient's own stem cells are used to help restore their bone marrow.

The purpose of this study is to evaluate how effective and safe this treatment approach is for patients with Hodgkin's lymphoma that is resistant to previous treatments. The study will also look at the potential of using a blood test to predict how well patients might respond to the treatment. This blood test measures the amount of DNA from Hodgkin's lymphoma cells circulating in the blood before the bone marrow transplantation.

Participants in the study will first receive nivolumab, followed by two cycles of the chemotherapy combination. Afterward, they will undergo the bone marrow transplantation. The study will monitor the patients to see how well the treatment works and to check for any side effects. The goal is to find out if this treatment can help patients achieve remission, which means the cancer is no longer detectable, and to understand how long patients can live without the disease getting worse.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of nivolumab treatment

    Receive nivolumab through an intravenous infusion. This is a medication designed to help the immune system fight cancer cells.

    The treatment involves three administrations of nivolumab. The exact schedule and dosage will be provided by the healthcare team.

  2. Step 2

    Chemotherapy with BGD

    After completing nivolumab treatment, begin chemotherapy with a combination of bendamustine, gemcitabine, and dexamethasone (BGD).

    This phase consists of two cycles of chemotherapy. The healthcare team will provide specific details on the timing and dosage of each medication.

  3. Step 3

    Autologous bone marrow transplantation

    Undergo an autologous bone marrow transplantation, which involves using your own stem cells to help restore bone marrow function after chemotherapy.

    This procedure is intended to consolidate the treatment and improve outcomes.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up appointments will be scheduled to monitor health and response to treatment.

    Assessments may include imaging tests and blood work to evaluate the effectiveness of the treatment and check for any side effects.

Who can join the trial?

11 criteria

  • Patients must have a recurrence of a type of cancer called **classical Hodgkin's lymphoma**. This must be confirmed by a local pathology report according to a specific classification from 2016.
  • Patients should have been initially diagnosed in certain stages of the disease, such as stage IIA with a large tumor or a massive lesion, or in stages IIB-IV.
  • Patients with **primary refractory classical Hodgkin's lymphoma** must meet specific criteria, such as having a large tumor or a massive lesion, or being in stages IIB-IV.
  • Primary resistance to treatment is defined by a positive test called **iPET2** after the second cycle of first-line chemotherapy. If the iPET2 test is negative, active disease must be confirmed by a PET-CT scan within three months after the first-line chemotherapy.
  • The advancement of the disease must be evaluated by a **PET examination** at diagnosis.
  • Patients must be **18 years or older**.
  • Patients must have an **ECOG** performance status of 0-2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • There must be at least one measurable change in the patient's condition.
  • Patients must agree to use effective contraception during the study. Women must use contraception for 14 months and men for 11 months after the last dose of treatment.
  • Women of childbearing age must have a negative pregnancy test at the start of the study and agree to use highly effective contraception during the study and for 14 months after the last dose of chemotherapy. This does not apply to women over 50 who have not had a period for at least 12 months or have had certain surgeries.
  • Patients must sign a consent form to participate in the clinical trial.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of cancer other than **Hodgkin's lymphoma**.
  • Patients who have not shown resistance or relapse after previous treatments for **Hodgkin's lymphoma**.
  • Patients who are not within the specified age range for the study.
  • Patients who are unable to undergo **BGD chemotherapy** or **autologous transplantation of hematopoietic stem cells**. **BGD chemotherapy** is a specific combination of cancer-fighting drugs, and **autologous transplantation of hematopoietic stem cells** is a procedure where a patient's own stem cells are used to help recover from high-dose chemotherapy.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial as an early second-line treatment for patients with Hodgkin's lymphoma who did not respond to their first treatment. It works by helping the immune system recognize and attack cancer cells more effectively.

  • Bendamustine

    is part of the chemotherapy regimen used in this trial. It is designed to kill cancer cells and slow down their growth by damaging their DNA.

  • Gemcitabine

    is another chemotherapy drug included in the treatment plan. It works by interfering with the DNA of cancer cells, preventing them from multiplying and spreading.

  • Dexamethasone

    is a steroid used in combination with other chemotherapy drugs. It helps reduce inflammation and can also help manage some side effects of chemotherapy.

  • Autologous Hematopoietic Stem Cell Transplantation (aHCT)

    is a procedure where a patient's own stem cells are collected, stored, and then given back to them after intensive chemotherapy. This helps restore the bone marrow and allows the body to produce healthy blood cells again.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently approved and widely used in the treatment of various cancers, including Hodgkin's lymphoma, particularly in cases where the disease has not responded to initial treatments. The main therapeutic indication for Nivolumab in this context is refractory or relapsed Hodgkin's lymphoma. At the molecular level, Nivolumab works by blocking the PD-1 protein on immune cells, which enhances the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and attack cancer cells more effectively.

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 often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. The progression of Hodgkin's lymphoma can vary, with some cases responding well to initial treatment, while others may become resistant or relapse. In refractory or relapsed cases, the disease does not respond to standard treatments or returns after a period of remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515064-31-00Protocol codeNBK132/2/2021Estimated enrolment84 patientsSponsorMedical University Of Gdansk

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).