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Study on the Effectiveness and Safety of Tislelizumab for Patients with Newly Diagnosed Hodgkin Lymphoma Who Cannot Have Standard Chemotherapy

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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 the effectiveness and safety of a treatment called tislelizumab for patients with a type of cancer known as Hodgkin lymphoma. Hodgkin lymphoma is a cancer that affects the lymphatic system, which is part of the body's immune system. The study is specifically for patients who have not received any previous treatment for their Hodgkin lymphoma and are considered unsuitable for standard chemotherapy, often due to other health conditions.

The purpose of the study is to evaluate how well tislelizumab works as a first-line treatment for these patients. Tislelizumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream. The study will monitor the overall response rate, which includes both complete and partial responses to the treatment. Participants will receive the treatment over a period of up to 24 months, and their health will be closely monitored throughout the study.

In addition to assessing the response to the treatment, the study will also look at other important factors such as how long the response lasts, the time patients remain free from disease progression, overall survival rates, and any side effects that may occur during and after the treatment. This information will help determine the potential benefits and risks of using tislelizumab for treating Hodgkin lymphoma in patients who cannot undergo standard chemotherapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, a histologically confirmed diagnosis of de novo classical Hodgkin lymphoma is required.
An informed consent form must be signed and dated, indicating understanding of the study's purpose and procedures.
Eligibility includes being 65 years or older and unsuitable for standard chemotherapy due to medical conditions.
Step 2
Initial assessment
An initial assessment will be conducted to ensure measurable disease is present, defined by fluorodeoxyglucose-avid nodal involvement and at least one nodal target lesion.
Adequate organ and marrow function must be confirmed, including specific blood count and liver function parameters.
Step 3
Treatment administration
The treatment involves the administration of tislelizumab intravenously.
The dosage and frequency of administration will be determined by the study protocol and medical team.
Step 4
Monitoring and follow-up
Regular monitoring will occur to assess the overall response rate, which includes complete and partial response rates.
Secondary assessments will include duration of response, progression-free survival, overall survival, and disease-free survival.
Step 5
Adverse event monitoring
The incidence and severity of adverse events will be monitored during therapy and up to 90 days after treatment.
Serious adverse events will be tracked from the signing of the informed consent to the end of the study.
Step 6
Study completion
The study is estimated to conclude by March 1, 2029.
Final assessments will be conducted to evaluate the long-term outcomes of the treatment.

Who can join the trial?

11 criteria

Must have a confirmed diagnosis of classical Hodgkin Lymphoma. This means the type of cancer has been identified through medical tests.
Must sign a form agreeing to participate in the study, showing they understand what the study involves.
Must be able to attend all study visits and follow the study requirements.
Must be 65 years or older and unable to receive standard chemotherapy due to other health issues.
Must not have received any treatment for Hodgkin Lymphoma before.
Must have a measurable disease, meaning the cancer can be seen and measured through medical imaging tests.
Must need treatment that affects the whole body, except for certain early-stage cases where radiation alone can cure the disease.
Must have an ECOG performance status of 2 or less. This is a scale that measures how well a person can perform daily activities.
Must have adequate organ and marrow function, meaning the body’s organs and blood cells are working well enough. This includes specific blood counts and kidney and liver function tests.
Must have a life expectancy of at least 6 months.
Men must agree to use effective birth control if sexually active, from the time they sign the consent form until 4 months after the last dose of the study drug.

Who cannot join the trial?

3 criteria

Patients who have already received treatment for Hodgkin lymphoma cannot participate. Hodgkin lymphoma is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
Patients who are suitable for chemotherapy are not eligible. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.
Patients who are part of a vulnerable population are not included. A vulnerable population may include groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

Verified
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alexandria, Italy
Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

Tislelizumab is a medication being studied for its effectiveness and safety as a first-line treatment for patients with newly diagnosed Hodgkin lymphoma who are not suitable for standard chemotherapy. It works by helping the immune system recognize and attack cancer cells. This study aims to determine how well tislelizumab can improve the overall response rate in these patients.

Tislelizumab

What is already known about the treatment

Tislelizumab – Tislelizumab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness and safety as a first-line treatment for patients with Hodgkin lymphoma who cannot undergo standard chemotherapy. The main therapeutic indication for tislelizumab is Hodgkin lymphoma. At the molecular level, tislelizumab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells. It is classified pharmacologically as an immune checkpoint inhibitor.

Investigated diseases

Hodgkin Lymphoma – Hodgkin 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. As the disease progresses, it can affect the body's ability to fight infections. Hodgkin Lymphoma is typically diagnosed through a biopsy of the affected lymph nodes.