Study on the Safety and Effectiveness of Epcoritamab with a 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 B-cell Non-Hodgkin Lymphoma. The main treatment being tested is a medication called Epcoritamab, which is also known by its code name GEN3013 or DuoBody-CD3xCD20. This medication is being combined with other treatments to see how safe and effective it is for people with this type of lymphoma. The purpose of the study is to evaluate the safety and preliminary effectiveness of these combinations.

Participants in the study will receive Epcoritamab along with other medications, which may include Dexamethasone Isonicotinate, Doxorubicin Hydrochloride, Prednisolone, Diphenhydramine, Cyclophosphamide, Vinblastine Sulfate, Betamethasone Sodium Phosphate, Buclizine Hydrochloride, Paracetamol, Codeine Phosphate, Anakinra, Rituximab, Bendamustine Hydrochloride, Cytarabine, Gemcitabine Hydrochloride, Tocilizumab, Carboplatin, Oxaliplatin, Etoposide, Ifosfamide, Siltuximab, and Lenalidomide. Some participants may receive a placebo instead of one of these medications. The study will be conducted in phases, starting with a dose escalation phase to determine the safest dose, followed by an expansion phase to further assess the treatment’s effectiveness.

Throughout the study, participants will be closely monitored for any side effects and changes in their condition. The study aims to gather information on how well the treatment works in reducing the size of the tumors and improving the overall health of the participants. The trial is expected to continue until 2028, with the goal of finding a safe and effective treatment option for people with B-cell Non-Hodgkin Lymphoma.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, a comprehensive health assessment is conducted to ensure eligibility for the trial. This includes a physical examination, blood tests, and imaging scans such as CT or MRI to measure any existing lesions.

The purpose of these tests is to confirm the presence of B-cell non-Hodgkin lymphoma and to assess overall health status. This step is crucial for determining the appropriate treatment plan.

2 treatment phase

The treatment phase involves receiving the study medication, epcoritamab, in combination with other agents. The administration of these medications is primarily through intravenous (IV) infusion, which means they are delivered directly into the bloodstream.

The frequency and dosage of the medications depend on the specific treatment arm assigned. This phase is designed to evaluate the safety and effectiveness of the medication combination.

3 monitoring and follow-up

Regular follow-up visits are scheduled to monitor health and response to the treatment. These visits include physical exams, blood tests, and imaging scans to track the progress of the disease and any side effects from the treatment.

The monitoring phase is essential for ensuring the safety and well-being of participants, as well as for collecting data on the treatment’s effectiveness.

4 end of treatment

At the end of the treatment period, a final evaluation is conducted. This includes a comprehensive assessment similar to the initial visit, with physical exams, blood tests, and imaging scans.

The purpose of this evaluation is to determine the overall response to the treatment and to gather data for the study’s conclusions.

5 long-term follow-up

After completing the treatment, long-term follow-up may be required. This involves periodic health assessments to monitor for any late effects of the treatment and to ensure continued health and safety.

Long-term follow-up is an important part of the study to understand the lasting impact of the treatment.

Who Can Join the Study?

The patient must sign an informed consent form (ICF), which is a document that explains the study and confirms their willingness to participate.
The patient must be at least 18 years old.
The patient must have a measurable disease, which means having at least one lymph node lesion that is larger than 1.5 cm in one direction and larger than 1.0 cm in another direction, or at least one lesion outside of the lymph nodes that is larger than 1.0 cm, as seen on a CT or MRI scan.
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2. This score measures how well the patient can perform daily activities, with 0 being fully active and 2 indicating some limitations.
The patient must have acceptable organ function at the time of screening.
The patient must have a type of non-Hodgkin lymphoma (NHL) that is positive for a protein called CD20, as confirmed by the most recent tumor biopsy.
If the patient is capable of having children, they must use a highly effective method of birth control.
If the patient is a man who is sexually active with a woman capable of having children, he must agree to use a barrier method of birth control, such as a condom.
The patient must have a life expectancy of more than 2 months with standard of care (SOC) treatment.
Specific requirements for different study groups (Arms) include having certain types of lymphoma or treatment history, such as:
- Arm 1: Certain types of diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) Grade 3B.
- Arm 2 and Arm 9: Relapsed or refractory follicular lymphoma (R/R FL).
- Arm 3: Newly diagnosed, previously untreated follicular lymphoma (FL) grade 1-3A.
- Arm 4 and Arm 10: Certain types of DLBCL or FL Grade 3B and eligible for high-dose therapy and autologous stem cell transplant (HDT-ASCT).
- Arm 5: Certain types of DLBCL or FL Grade 3B and ineligible for HDT-ASCT.
- Arm 6: Previously untreated CD20-positive follicular lymphoma (FL).
- Arm 7: Follicular lymphoma (FL) in complete or partial remission according to Lugano criteria after first-line or second-line treatment with SOC, with the last dose of SOC within 6 months before enrollment.
- Arm 8: Certain types of DLBCL or FL Grade 3B, and ineligible to receive full-dose anthracycline as part of R-CHOP treatment.
- Arm 9: Must have received only one prior line of therapy, which included an anti-CD20 antibody with chemotherapy, and the disease progressed within 24 months of starting the first-line treatment.

Who Cannot Join the Study?

Patients with any other type of cancer besides Lymphoma of B-cell origin cannot participate.
Patients who have had a severe allergic reaction to similar medications in the past are not eligible.
Patients with uncontrolled infections or serious illnesses that could interfere with the study are excluded.
Pregnant or breastfeeding women cannot take part in the study.
Patients who have received another experimental treatment within the last 4 weeks are not allowed to join.
Patients with certain heart conditions that are not stable are excluded.
Patients with a history of drug or alcohol abuse that could affect their ability to participate are not eligible.
Patients who are unable to follow the study procedures or attend the required visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Oslo Universitetssykehus HF	Oslo	Norway
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
University Hospital Ostrava	Ostrava	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Hopital Beaujon	Clichy	France
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Hujljbmw Vlkv dyhtqtqr	Barcelona	Spain
Fgiqxanx nttlwkpuj Mpjem a Hijejpw	Prague	Czechia
Ovehxk Utdxaygqvw Hiivyszl	Odense	Denmark
Fwjkkhgvhj Ikakt Cr Gbwewe Onprbdhw Mzcowqms Pykrtocepzp	Milan	Italy
Fhudxmanuq Ipwct Ponaovzwivq Sux Mznwdq	Pavia	Italy
Iwkvuzsj Rycnsxihd Pja Lh Sslijc Dkj Tpjqup Dryi Albjtbw Ieee Srqbqm	Meldola	Italy
Aojisapoy Upl	Amsterdam	The Netherlands
Azzdpwouhj Pzcphwcm Htngfher Db Mdhhwshze	Marseille	France
Rxthzf Spwpz Sjfxlx Ulplsukvarfddfutkrt	Lund	Sweden
Utmhiaroslzl Mlqhjmx Cddjdzk Uxmulns	Utrecht	The Netherlands
Ublkgzp Utrokozfkr Hokawtjg	Uppsala	Sweden
Hhazbclm Uyrwvpxcer Cxebvwk Hijgdryz	Helsinki	Finland
Estqulz Uejbqwwsxktj Mdwcwqc Cwrtlci Rsjzpzgzp (usqhzsw Mea	Rotterdam	The Netherlands
Hjsbqeqw Uhhcywfdvbvyb Fzgdsiytv Jkvyoez Djeg	Madrid	Spain
Vcscpoemb Fbqtlwqx Nnzsgqoie V Panpb	Prague	Czechia
Uvhftckbxg Hpftorzp Myfhwxdroq	Maastricht	The Netherlands
Rfhylhcqzffgnz	Copenhagen	Denmark
Aiviqig Udses Skjivotas Lbxxqj Da Bduhgvm	Bologna	Italy
Axmsstj Orvxjhcslnx Pqtk Ggvbwchy Xpdkw	Bergamo	Italy
Uxgvuyumfuyb Zqrfbeaabe Giow	Gent	Belgium
Uuvdadkgbnfg Mwuuwst Cddwfrf Gvdyhnatq	Groningen	The Netherlands
Cxefvd Hyijmqokyjk Lwbc Sof	Pierre Benite	France
Iypkflos Ctsnkg Dupnyynxlrmkfcudn	L'hospitalet De Llobregat	Spain
Qvevl Snolny Cwuwgpiyf Hjlqoxsa &pzukhb Suikrugbkli Uhaxfsitxa Hpekmbtk &xprjxi Vmbskih Gwfpzfjvhlunlvemwa	Gothenburg	Sweden
Fpajizwpk Pzuz Le Isfceqsckezej Biiscndhz Dat Hsajpzxw Uxlvoxqaberrf Lf Pva	Madrid	Spain
Cvzctg Huxhpfayxnn Uvonmtxdhngqi Dmbhmm Gkfetop Sdmubqkpivqpecnxxahetnnsby	Namur	Belgium
Idtwfixr Dg Cwrjjowd Fnjmmhigpd Dyh Pehgbbvz Pky Lietlclzdx Irtrk	Candiolo	Italy
Aftqoj Uwnthktvdc Hdlwfoiv	Aarhus	Denmark
Aoywezg Uax Iqzlt Db Rxskbb Ebemlh	Reggio Emilia	Italy
Llyvw Udbirqcninae Mjfiubd Crwuchz (qwcst	Leiden	The Netherlands
Szfeit Afpvldmnl Hcdgffcb Vzrojhr Giequcdzgkmahvfjec	Boras	Sweden

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2020
Czechia	Not recruiting	01.07.2020
Denmark	Not recruiting	01.07.2020
Finland	Not recruiting	01.07.2020
France	Not recruiting	01.07.2020
Italy	Not recruiting	01.07.2020
Norway	Not recruiting	01.07.2020
Spain	Not recruiting	01.07.2020
Sweden	Not recruiting	01.07.2020
The Netherlands	Not recruiting	01.07.2020

Trial locations

Investigated Drugs:

Epcoritamab is a type of treatment that helps the body’s immune system fight cancer. It is designed to target specific proteins found on the surface of certain cancer cells, particularly in B-cell Non-Hodgkin Lymphoma. By binding to these proteins, it helps the immune system recognize and destroy the cancer cells. In this trial, Epcoritamab is being tested to see how safe it is and how well it works when used with other treatments.

Lymphoma of B-cell origin – Lymphoma of B-cell origin is a type of cancer that begins in the B lymphocytes, which are a type of white blood cell responsible for producing antibodies. It typically starts in the lymph nodes but can also affect other organs. The disease progresses as the abnormal B cells multiply uncontrollably, forming tumors in the lymphatic system. Over time, these cancerous cells can spread to other parts of the body, including the bone marrow, spleen, and liver. As the disease advances, it can interfere with the body’s ability to fight infections. The progression of the disease can vary, with some forms growing slowly and others more aggressively.

Trial ID:

2023-504805-35-00

Protocol code:

GCT3013-02

NCT ID:

NCT04623541

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Epcoritamab with a 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?