Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Non-Hodgkin Lymphoma, specifically a subtype known as B-cell Non-Hodgkin’s lymphoma. The study is testing a treatment called Epcoritamab, which is a type of medicine known as a bispecific antibody. This treatment will be used in combination with other cancer-fighting drugs, also known as anti-neoplastic agents. The main goal of the study is to understand how safe and tolerable Epcoritamab is when used with these other drugs.

Participants in the study will receive Epcoritamab along with other medications, which may include Revlimid (containing lenalidomide), Decortin (containing prednisolone), Cyclophosphamide, Truxima (containing rituximab), IMBRUVICA (containing ibrutinib), Venetoclax (also known as ABT-199), Adriblastin (containing doxorubicin hydrochloride), Polivy (containing polatuzumab vedotin), and Golcadomide (also known as BMS-986369/CC-99282). Some participants may receive a placebo instead of one of these medications. The study will help determine the best dose of Epcoritamab to use in future research.

The study will take place over several years, with participants receiving treatment and being monitored for any side effects or changes in their condition. The researchers will look at how the cancer responds to the treatment, how long any positive effects last, and how long it takes for the cancer to progress or for participants to need another type of treatment. This information will help doctors understand how effective Epcoritamab is when used with other cancer treatments for people with B-cell Non-Hodgkin’s lymphoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

Diagnostic tests such as PET/CT scans are performed to identify measurable disease sites.

2 treatment phase 1

The first phase of treatment involves the administration of epcoritamab in combination with other medications.

Medications include lenalidomide (Revlimid) taken orally in capsule form, prednisolone (Decortin) in tablet form, and cyclophosphamide administered intravenously.

The frequency and dosage of these medications are determined by the study protocol and adjusted based on individual response and tolerance.

3 treatment phase 2

In the second phase, additional medications such as rituximab (Truxima) and ibrutinib (IMBRUVICA) are introduced.

Rituximab is given as an infusion, while ibrutinib is taken orally in capsule form.

The treatment continues with regular monitoring to assess safety and effectiveness.

4 treatment phase 3

The third phase includes the administration of venetoclax and epcoritamab.

Venetoclax is taken orally as a film-coated tablet, and epcoritamab is given as a subcutaneous injection.

The treatment regimen is adjusted based on the patient’s response and any side effects experienced.

5 treatment phase 4

In the final phase, additional medications such as doxorubicin hydrochloride (Adriblastin) and polatuzumab vedotin (Polivy) are administered.

Doxorubicin is given intravenously, while polatuzumab is provided as an infusion.

The treatment aims to maximize therapeutic benefits while minimizing adverse effects.

6 follow-up and monitoring

After completing the treatment phases, regular follow-up visits are scheduled to monitor health status and response to treatment.

These visits may include physical examinations, imaging tests, and laboratory assessments to evaluate the effectiveness and safety of the treatment.

Who Can Join the Study?

Must be an adult, male or female, at least 18 years old.
Must have a diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL), which is a type of cancer that affects the lymphatic system. This can be a new diagnosis or a transformation from other types of lymphoma.
The disease must be confirmed as CD20+, which means the cancer cells have a specific protein on their surface.
Must have an ECOG performance status of 0 to 2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
Must have at least one measurable site of disease. This means there should be a tumor that can be seen and measured using imaging tests like a PET/CT scan. The tumor should be at least 1.5 cm in size if it’s in a lymph node, or at least 1.0 cm if it’s outside a lymph node.

Who Cannot Join the Study?

Patients who have a different type of cancer than B-cell Non-Hodgkin’s lymphoma or diffuse large B-cell lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to safely receive the study treatment due to other health conditions cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have certain infections or diseases that could interfere with the study cannot participate.
Patients who are unable to follow the study procedures or attend required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Universitaet Leipzig	Leipzig	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
University Of Debrecen	Debrecen	Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Philipps-Universitaet Marburg	Marburg	Germany
Semmelweis University	Budapest	Hungary
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Aalborg University Hospital	Aalborg	Denmark
Centre Hospitalier Universitaire De Nantes	Nantes	France
Region Midtjylland	Aarhus	Denmark
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Universitaire De Rennes	Rennes	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
University Hospital Ostrava	Ostrava	Czechia
Loqkd Ukegvzmoyynz Mhnzoil Crzhgnk (iazya	Leiden	The Netherlands
Udmmbdnwgmll Mezmmby Csdvwtu Gptyarezs	Groningen	The Netherlands
Ummtbdjvchpaqvqdcpnno Ajsvdnop	Augsburg	Germany
Iljdmbox Ctdafu Dxqhremaahmumhqxo	L'hospitalet De Llobregat	Spain
Uiaocilqzy Hzqhenpvb Pjalj Sdgqywdajni Cplmnli Fupc	Paris	France
Aeriapbfu Uzi	Amsterdam	The Netherlands
Ahsatqufnf Plgxjwii Hsuhlrye De Pzzhd	Paris	France
Csqu Di Nmyxs	Vandoeuvre Les Nancy	France
Uewvzqagghlgpcnoroplu Wzuuemdun Ado	Wuerzburg	Germany
Hoeidjem Vrkq dydxnknt	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	20.06.2022
Denmark	Recruiting	20.06.2022
France	Recruiting	20.06.2022
Germany	Recruiting	20.06.2022
Hungary	Recruiting	20.06.2022
Spain	Recruiting	20.06.2022
The Netherlands	Recruiting	20.06.2022

Trial locations

Investigated drugs:

Epcoritamab is a medication being studied for its safety and how well it is tolerated when used with other cancer-fighting drugs in people with a type of cancer called Non-Hodgkin Lymphoma. The goal is to find out how safe it is and to determine the best dose to use in future studies.

Investigated diseases:

B-cell Non-Hodgkin’s Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-lymphocytes, which are a type of white blood cell. It is characterized by the uncontrolled growth of these cells, which can form tumors in lymph nodes and other parts of the body. The disease can vary in its progression, with some forms being slow-growing and others more aggressive. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The exact cause of B-cell Non-Hodgkin’s Lymphoma is not well understood, but it involves genetic mutations in the B-cells.

Diffuse Large B-cell Lymphoma – This is a specific subtype of B-cell Non-Hodgkin’s Lymphoma and is considered the most common form of this disease. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease progresses quickly and requires prompt medical attention. Symptoms often include swelling of lymph nodes, fever, night sweats, and unexplained weight loss. The cause of Diffuse Large B-cell Lymphoma is not fully known, but it involves genetic changes in the B-cells.

Trial ID:

2023-505347-38-00

Protocol code:

M22-132

NCT ID:

NCT05283720

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?