Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
Not recruitingRare disease
Study of Tislelizumab, Dacarbazine, Vinblastine Sulfate, and Doxorubicin Hydrochloride for Adults with Early-Stage Unfavorable Hodgkin 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 Early-Stage Unfavorable Classical Hodgkin Lymphoma. The trial aims to explore a new treatment approach that includes a medication called Tislelizumab, which is a form of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer. The study will also use other medications, including Dacarbazine, Vinblastine Sulfate, and Doxorubicin Hydrochloride, which are commonly used in cancer treatment. These medications will be given as infusions, which means they are delivered directly into the bloodstream through a vein.
The purpose of this study is to find out how effective and well-tolerated this new treatment plan is for patients with this type of Hodgkin Lymphoma. The study will follow a specific plan where patients will receive the medications over a period of time. The treatment will be guided by a special type of scan called a PET scan, which helps doctors see how the cancer is responding to the treatment. The study will last for several years, and patients will be monitored to see how well they do over time.
Participants in the study will receive either the new treatment plan or a standard treatment, which may include a placebo. The study will look at various outcomes, such as how long patients remain free from cancer progression and their overall survival rates. It will also consider the quality of life reported by the patients during and after the treatment. The goal is to provide a more personalized treatment option for patients with this type of cancer, potentially improving their outcomes and quality of life.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Age between 18 and 60 years on the day of signing the consent form.
- For an exploratory group, age 61 years or older on the day of signing the consent form.
- Eligible for 4 cycles of AVD chemotherapy (exploratory group only).
- Total CIRS-G score less than 10 and score 3 or less for each organ system. Note: Certain conditions related to Hodgkin Lymphoma are not counted in this score (exploratory group only).
- First diagnosis of Hodgkin Lymphoma confirmed by a tissue sample.
- No previous treatment for Hodgkin Lymphoma, except for corticosteroids if needed.
- Early-stage unfavorable Hodgkin Lymphoma as defined by specific criteria, including certain stages and risk factors.
- Able to provide written consent and agree to follow the trial requirements, including using contraception and attending scheduled assessments.
- Estimated life expectancy of more than 3 months.
- Adequate organ function as shown by specific medical tests, with exceptions for conditions related to Hodgkin Lymphoma.
- For women who can have children: Must use effective birth control, not breastfeed, and have a negative pregnancy test before starting the trial.
- For men who are not sterile: Must use barrier methods like condoms for birth control and not donate sperm during the trial and for 6 months after the last treatment.
Who cannot join the trial?
13 criteria
- Patients who have a different type of cancer other than Early-Stage Unfavorable Classical Hodgkin Lymphoma.
- Patients who are younger than 18 years old or older than 60 years old.
- Patients who are pregnant or breastfeeding.
- Patients who have a serious infection that is not controlled.
- Patients who have a history of another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer.
- Patients who have an autoimmune disease, which is when the body's immune system attacks its own healthy cells.
- Patients who have received a live vaccine within 30 days before starting the study treatment.
- Patients who have a known allergy to the study drug or its ingredients.
- Patients who have a history of heart disease that is not well controlled.
- Patients who have a history of lung disease that is not well controlled.
- Patients who have a history of liver disease that is not well controlled.
- Patients who have a history of kidney disease that is not well controlled.
- Patients who are currently participating in another clinical trial.
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Verified sites
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Verified Verified Charite Universitaetsmedizin Berlin KöR
Berlin, GermanyResponsive Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
Trial locations
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Investigated drugs
Tislelizumab is a type of medication known as a checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, tislelizumab is being used as part of a personalized treatment plan for patients with early-stage unfavorable Hodgkin Lymphoma. The goal is to see if adding tislelizumab to the treatment can improve outcomes for patients by stopping the cancer from growing or spreading for at least a year.
What is already known about the treatment
Tislelizumab – Tislelizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating early-stage unfavorable classical Hodgkin lymphoma, a type of cancer. The medication works by blocking a specific protein on the surface of immune cells, which helps the body's immune system recognize and attack cancer cells more effectively. Tislelizumab is classified as an immune checkpoint inhibitor, a type of drug that helps boost the immune response against cancer.
Investigated diseases
Early-Stage Unfavorable Classical Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting a type of white blood cell called lymphocytes. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. In its early stages, the disease is typically localized to a limited number of lymph nodes or a single region of the body. As it progresses, it can spread to other lymph nodes and organs, such as the spleen, liver, or bone marrow. The disease is termed "unfavorable" due to certain risk factors that may include large tumor size or involvement of multiple lymph node regions. The progression of the disease can vary, but it generally involves the gradual spread of cancerous cells through the lymphatic system.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500571-32-00Protocol codeUni-Koeln-4470Estimated enrolment120 patientsSponsorUniversity Of Cologne
sourced from the EU Clinical Trials Register and site verification
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