Ongoing Clinical Trials for Refractory Hodgkin’s Disease
Currently, there are 4 ongoing clinical trials investigating new treatment approaches for patients with refractory Hodgkin’s disease. These studies are testing different combinations of immunotherapy and chemotherapy drugs across several European countries, including Italy, Poland, Spain, and Czechia. The trials focus on patients whose disease has not responded to initial treatments or has returned after previous therapy.
Clinical trial locations
- Czechia
- Italy
- Poland
- Spain
Study of Nivolumab and Chemotherapy Combination for Patients with Refractory Hodgkin’s Lymphoma
This trial is investigating a combination treatment approach for patients whose disease has not responded to initial therapy. The study is being conducted in Poland and focuses on using immunotherapy followed by chemotherapy and a bone marrow transplant.
Who can participate: Patients must be 18 years or older with confirmed classical Hodgkin’s lymphoma that is primary refractory, meaning it did not respond to the first treatment. The disease must have been diagnosed in specific stages and confirmed through PET testing after the second cycle of first-line chemotherapy. Participants need to have at least one measurable tumor and an ECOG performance status of 0-2, which measures how well patients can perform daily activities. Women of childbearing age must use effective contraception for 14 months after treatment, and men for 11 months.
Who cannot participate: Patients with a different type of cancer, those who have not shown primary resistance to treatment, individuals outside the specified age range, patients unable to undergo the chemotherapy regimen or bone marrow transplant, those with serious health conditions that might interfere with the study, and pregnant or breastfeeding women are excluded.
Treatment approach: The study uses nivolumab, an immunotherapy drug that helps the immune system recognize and attack cancer cells. This is followed by two cycles of chemotherapy with bendamustine, gemcitabine, and dexamethasone. After chemotherapy, patients undergo an autologous bone marrow transplantation, where their own stem cells are used to help restore bone marrow function. The study also includes a blood test that measures DNA from cancer cells to potentially predict treatment response.
Study focus: The main goal is to evaluate how effective and safe this treatment sequence is for patients with resistant disease. Researchers will monitor participants to determine if the treatment can help achieve remission and understand how long patients can live without disease progression.
Study of Ruxolitinib with Brentuximab or Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin Lymphoma
This Italian trial tests combination treatments for patients whose disease has returned or not responded to previous therapy. The study has two groups: one receiving ruxolitinib with brentuximab vedotin, and another receiving ruxolitinib with pembrolizumab.
Who can participate: Patients must be 18 years or older with confirmed relapsed or refractory classical Hodgkin lymphoma. For the first group, patients must have CD30-positive disease that relapsed or is refractory after autologous stem cell transplantation, or after at least two previous treatments if transplant is not suitable. For the second group, patients must have received similar prior treatments. All participants need at least one measurable tumor on PET-CT scan, an ECOG performance status of 0-1 or 0-2 depending on the group, and a life expectancy of at least 5 months.
Who cannot participate: Patients who only had a partial response to their last treatment, those who have not shown any improvement or whose condition has worsened, are not eligible.
Treatment approach: Ruxolitinib works by blocking proteins involved in cancer cell growth and survival. It is combined with either brentuximab, which targets and destroys cancer cells by binding to a specific protein on their surface, or pembrolizumab, which helps the immune system fight cancer by blocking a protein that prevents immune attack. The combination aims to improve response rates compared to previous treatments.
Study focus: The primary goal is to determine the rate of complete response, meaning the cancer has disappeared, during or at the end of treatment. The study also explores whether these treatments can prepare patients for stem cell transplants and searches for markers that might predict treatment response. The trial is expected to continue until 2026.
Study on the Safety of HSP-CAR30 Immunotherapy for Patients with Relapsed or Refractory CD30+ Hodgkin and Non-Hodgkin Lymphoma
This Spanish trial investigates an innovative immunotherapy approach using patients’ own modified immune cells. The study focuses on evaluating the safety of this new treatment method.
Who can participate: Patients must be between 18 and 80 years old with good general health status (ECOG 0 or 1). For patients with classical Hodgkin’s disease, eligibility includes those who relapsed after autologous transplant and previously received brentuximab vedotin and anti-PDL1 antibodies without achieving complete remission, or primary refractory patients who did not achieve complete remission after rescue treatments. Lung function tests should show FEV1, DLCO, and FVC values greater than 39% of normal, and heart function must show left ventricular ejection fraction greater than 45%. Liver and kidney function must meet specific requirements, and tests for HIV, HBV, and HCV must be negative. The disease must be measurable on PET-CT scan.
Who cannot participate: Patients with other types of cancer, those not experiencing relapse or refractory condition, individuals outside the specified age range, or those who do not meet safety and health requirements cannot participate.
Treatment approach: HSP-CAR30 involves taking a patient’s T cells and modifying them in the laboratory to better recognize and attack cancer cells expressing the CD30 protein. The modified cells are then infused back into the patient. Before receiving the modified cells, patients undergo preparation with medications including bendamustine hydrochloride, fludarabine phosphate, and cyclophosphamide monohydrate. Additional medication called tocilizumab may be used to manage side effects.
Study focus: The main goal is to assess the safety and potential side effects of this cell-based therapy. Researchers will closely monitor patients for 30 days after treatment to identify any dose-limiting toxicity and evaluate how well the treatment works. The study will continue until the end of 2025.
Study of Pembrolizumab for Patients with Relapsed or Refractory Classical Hodgkin’s Lymphoma or Primary Mediastinal Large B-cell Lymphoma
This multinational trial, conducted in Italy, Poland, and Czechia, tests pembrolizumab as a treatment for patients whose disease has returned or not responded to previous therapy.
Who can participate: Both males and females with confirmed diagnosis of classical Hodgkin’s lymphoma or primary mediastinal large B-cell lymphoma can participate. The disease must be measurable using imaging tests, with at least one lymph node larger than 15 mm that has not been treated with radiation, or a tumor outside lymph nodes larger than 10 mm in both directions. For primary mediastinal large B-cell lymphoma patients, the disease must have relapsed after a stem cell transplant. For classical Hodgkin’s lymphoma patients, relapse must have occurred during the last treatment plan after at least two cycles, or within 12 months after finishing the last treatment.
Who cannot participate: Patients who have not experienced relapse or disease that did not respond to treatment, or individuals outside the specified age range are excluded.
Treatment approach: Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells by blocking a specific protein on immune cells. The medication is given as an intravenous infusion every six weeks at a dosage of 25 mg/mL.
Study focus: The trial aims to evaluate how well pembrolizumab works in shrinking or controlling the cancer. Throughout the study, participants undergo regular check-ups and tests to assess their health and treatment progress. Researchers will measure the objective response rate using the Lugano classification criteria, as well as the duration of response and any adverse events. The study is expected to continue until the end of 2025.
Summary
These four ongoing clinical trials represent diverse approaches to treating refractory Hodgkin’s disease across Europe. The studies are geographically distributed, with trials taking place in Poland, Italy, Spain, and Czechia, providing access to innovative treatments for patients in multiple countries.
A notable pattern is the focus on immunotherapy approaches. Three of the four trials utilize immune checkpoint inhibitors such as nivolumab and pembrolizumab, which work by enhancing the body’s natural immune response against cancer cells. One trial explores the innovative CAR-T cell therapy approach, representing the cutting edge of personalized cancer treatment.
The trials primarily target patients who have exhausted conventional treatment options, including those who have relapsed after autologous stem cell transplantation or who have not responded to multiple lines of therapy. This addresses a significant unmet medical need for this patient population.
Several drugs appear across multiple trials, particularly pembrolizumab, which is being studied both as a single agent and in combination with other medications. This reflects the growing body of evidence supporting immunotherapy in treating refractory lymphomas. The combination approaches being tested suggest that researchers are working to improve outcomes beyond what single agents can achieve.
All trials emphasize safety monitoring, recognizing that patients with refractory disease often have complex medical histories and may be more vulnerable to treatment-related complications. The studies include comprehensive eligibility criteria to ensure participants can safely undergo the investigational treatments while providing valuable data on effectiveness and safety.