Study of Tislelizumab, Gemcitabine, and Cisplatin for Patients with Relapsed or Refractory Hodgkin Lymphoma in Metabolic Complete Remission

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What is this study about?

This clinical trial is focused on studying a type of cancer called Hodgkin lymphoma, which is a cancer of the lymphatic system. The study is testing a combination of treatments to see how effective they are for patients whose disease has returned or has not responded to initial treatments. The treatments being studied include Tislelizumab, a medication that helps the immune system fight cancer, and two chemotherapy drugs, Gemcitabine and Cisplatin. These medications are given to patients to see if they can help control the cancer and improve the chances of staying cancer-free for longer periods.

The purpose of the study is to evaluate how well this combination of treatments works in preventing the cancer from getting worse or coming back over a period of two years. Patients will receive the combination of Tislelizumab, Gemcitabine, and Cisplatin initially, followed by additional doses of Tislelizumab if they achieve a complete remission, meaning no signs of cancer are detected. The study will monitor patients’ health and response to the treatment over time to gather information on the effectiveness and safety of these medications.

Participants in the study will receive the treatments through intravenous infusions, which means the medications are given directly into a vein. The study will last for several months, with regular check-ups and assessments to track the progress of the treatment. The goal is to find out if this treatment approach can help patients with relapsed or refractory Hodgkin lymphoma live longer without their disease progressing.

1 initial treatment phase

Upon joining the study, you will begin the initial treatment phase. This phase involves receiving a combination of medications to treat Hodgkin lymphoma.

You will receive gemcitabine and cisplatin through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein.

Additionally, you will receive tislelizumab through an intravenous infusion. The exact dosage and frequency will be determined by the study team based on your specific needs.

2 monitoring and assessment

Throughout the treatment, regular monitoring will be conducted to assess your response to the medications. This includes imaging tests such as FDG-PET/CT scans to evaluate the size and activity of the lymphoma.

Your healthcare team will also monitor for any side effects or adverse reactions to the treatment. It is important to report any new symptoms or concerns to the study team promptly.

3 consolidation phase

If you achieve a metabolic complete remission, meaning the lymphoma shows no signs of activity, you will enter the consolidation phase.

During this phase, you will continue to receive tislelizumab to help maintain remission. The frequency and duration of this treatment will be determined by the study protocol.

4 follow-up and evaluation

After completing the treatment phases, you will enter a follow-up period. This involves regular check-ups and assessments to monitor your health and ensure the lymphoma remains in remission.

The study aims to evaluate progression-free survival, which is the length of time you remain free from lymphoma progression or recurrence.

Who Can Join the Study?

Must have a confirmed diagnosis of classical Hodgkin lymphoma (a type of blood cancer).
Must be able to attend all study visits and follow the study requirements.
If female, must have a negative pregnancy test at the start of the study.
If female and able to have children, must agree to use two effective methods of birth control or abstain from heterosexual intercourse during the study and for 6 months after the last dose of the study drug.
If male, must agree to use effective barrier contraception or abstain from heterosexual intercourse during the study and for 6 months after the last dose of the study drug.
Must provide written informed consent, meaning you understand and agree to participate in the study.
Must be able to understand and give consent to participate in the study.
Must have primary refractory disease (meaning the cancer did not respond to initial treatment) or be in the first relapse after previous chemotherapy.
If the disease has returned, it must be confirmed by a biopsy or other medical imaging tests.
Must have measurable disease according to specific medical criteria, meaning the cancer can be seen and measured on a CT scan.
Must be between 18 and 70 years old.
Must have a WHO/ECOG Performance Status of 0 or 1, indicating you are fully active or have some symptoms but can carry out light work.
Must not have major organ dysfunction unless it is related to Hodgkin lymphoma. This includes specific limits on liver and kidney function tests.
Must have adequate bone marrow function, which means having enough healthy blood cells.
Must have resolved any side effects from previous treatments.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 5 years, except for skin cancer that is not melanoma.
Patients who have an active infection that requires treatment.
Patients who have received a live vaccine within 30 days before starting the study treatment.
Patients who have had an organ transplant.
Patients who are allergic to any of the study drugs or their ingredients.
Patients who have a history of autoimmune disease, which is when the body’s immune system attacks its own tissues.
Patients who have uncontrolled high blood pressure or heart disease.
Patients who have a history of drug or alcohol abuse within the last year.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Meander Medical Center	Amersfoort	The Netherlands
Universitair Medisch Centrum Groningen	Groningen	The Netherlands
Medisch Centrum Leeuwarden B.V.	Leeuwarden	The Netherlands
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Spaarne Gasthuis	Hoofddorp	The Netherlands
Maxima Medisch Centrum	Veldhoven	The Netherlands
Odense University Hospital	Odense	Denmark
Haga Hospital	Hague	The Netherlands
Astjnsckrm Ztrzzgvreu Mpquqbzmje	Maastricht	The Netherlands
Cuctdpxft Uqxbfrplyikzuw Sjxchyyyi	Woluwe-Saint-Lambert	Belgium
Axvphkfe Di Rsjvqa Zimiodbkcs Bqui	Goes	The Netherlands
Agrhbhxnb Uky	Amsterdam	The Netherlands
Eoquoqe Uekhfquvvqzq Mectykw Camacfy Rbucoperx (zvrbmcr Mbt	Rotterdam	The Netherlands
Rkaipxcxq Zmgblggvmv Sjainupoa	Arnhem	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.04.2023
Denmark	Not recruiting	15.04.2023
The Netherlands	Not recruiting	15.04.2023

Trial locations

Investigated drugs:

Tislelizumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used both in combination with other drugs and on its own to help treat Hodgkin Lymphoma that has come back or has not responded to previous treatments.

Gemcitabine is a chemotherapy drug that helps stop the growth of cancer cells by interfering with their DNA. It is used in this trial to help treat Hodgkin Lymphoma by working together with other medications to attack the cancer cells.

Cisplatin is another chemotherapy medication that works by damaging the DNA of cancer cells, which prevents them from growing and dividing. In this trial, it is used alongside other treatments to help fight Hodgkin Lymphoma that has returned or is resistant to other treatments.

Investigated diseases:

Hodgkin's disease

Hodgkin lymphoma – Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, which is part of the 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, bone marrow, and lungs. As it progresses, it may cause symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Hodgkin lymphoma can vary, with some cases advancing slowly and others more rapidly. The disease is often identified through a combination of physical examination and imaging studies.

Trial ID:

2022-502225-17-00

Protocol code:

HO164

NCT ID:

NCT05502250

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tislelizumab, Gemcitabine, and Cisplatin for Patients with Relapsed or Refractory Hodgkin Lymphoma in Metabolic Complete Remission

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