Study of Tislelizumab, Dacarbazine, Vinblastine Sulfate, and Doxorubicin Hydrochloride for Adults with Early-Stage Unfavorable Hodgkin Lymphoma

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What is this study about?

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.

1 initial assessment

Upon joining the clinical trial, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the trial is suitable for participation.

2 treatment plan discussion

A detailed discussion about the treatment plan will take place. This includes information about the medications, their purpose, and the schedule for administration.

3 medication administration

The treatment involves the administration of several medications through infusion. These medications include dacarbazine, tislelizumab, vinblastine sulfate, and doxorubicin hydrochloride. Each medication will be given according to a specific schedule determined by the healthcare team.

4 monitoring and follow-up

Regular monitoring will be conducted to assess the response to treatment and manage any side effects. This includes scheduled visits for physical examinations, blood tests, and imaging studies as needed.

5 completion of treatment

Upon completion of the treatment regimen, a final assessment will be conducted to evaluate the overall response to the therapy. This includes a review of all test results and a discussion about the next steps in care.

6 long-term follow-up

Long-term follow-up will be scheduled to monitor health status and ensure any late effects of treatment are managed appropriately. This may involve periodic check-ups and additional tests as recommended by the healthcare team.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Rostock University Medical Center	Rostock	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH	Trier	Germany
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
Rostock University Medical Center	Rostock	Germany
Vincentius-Diakonissen-Kliniken gAG	Karlsruhe	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Saarland University Hospital	Homburg	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH	Paderborn	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Ortenau Klinikum	Offenburg	Germany
Gesundheit Nord gGmbH Klinikverbund Bremen	Bremen	Germany
Klinikverbund Allgaeu gGmbH	Kempten (Allgau)	Germany
Knaieqxg Lvziqrlb Azgof Dnl Syaml Lmlazcys	Landshut	Germany
Rjorwjfzznlahc Izccwpvf Dxd vok Ehdyf Rwgmknrezehzf Pbbvkewedbgiw Dxd Sylnepsj Dku Wslcqyp Dcn Gfckeovp Dwy Vitddv Dmd Hfei Dyl Kwcs Dnw Aqafhholwysgf Dhn Kunbov Pd Dfc Gejw Dgk Ethb Diu Mveoi Dtl Ssmbax Amteab fqpe Ritvbkskgr Nyunikvyrsvkwpt Sgoilogjkzifxcoi ufq Nbkyotqcjsaokx	Koblenz	Germany
Gbtpvjgtvlfcsskkrxlli Mralpbmutew gyfdd	Koblenz	Germany
Vfpuo Cjkqujfwkjq Kzebssvn Kqqqiwrep	Karlsruhe	Germany
Uashizlrgu Htzzkerz Cdukjmf	Cologne	Germany
Goivsv Upfolvmmzu Faihknyif	Frankfurt	Germany
Kfmwikxt dbe Untnakmlkxbc Mielhsak Avf	Munich	Germany
Uhjajjequuufnldnrfzmk Wieneesad Ars	Wuerzburg	Germany
Uccrndrvfr Mknoqnw Caxcdg Hgmyqjrrsmpaddrrw	Hamburg	Germany
Urdyeyxnczehlukyffhxk Ecjym Aol	Essen	Germany
Uysyhrwqvodalbrrzvfac Azswrnod	Augsburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.12.2023

Trial locations

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.

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 ID:

2022-500571-32-00

Protocol code:

Uni-Koeln-4470

NCT ID:

NCT04837859

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tislelizumab, Dacarbazine, Vinblastine Sulfate, and Doxorubicin Hydrochloride for Adults with Early-Stage Unfavorable Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?