Study Comparing Epcoritamab with Chemotherapy for Patients with Relapsed or Refractory B-cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL), which is a common form of non-Hodgkin lymphoma. The trial is comparing the effectiveness of a new treatment called Epcoritamab against standard chemotherapy options chosen by the investigator. Epcoritamab is a type of medication known as a monoclonal antibody, which is designed to help the immune system target and destroy cancer cells. The standard chemotherapy options in this study include combinations like Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) or Bendamustine and Rituximab (BR).

The purpose of the study is to compare how well Epcoritamab works compared to these standard treatments. Participants in the study will be randomly assigned to receive either Epcoritamab or one of the standard chemotherapy treatments. The study will monitor participants over a period to assess their overall survival, which means how long they live after starting the treatment, and other factors like how long they remain free from cancer progression. The study will also look at the response rate, which is how many participants see a reduction in their cancer, and the duration of response, which is how long the cancer remains reduced.

Participants will receive their assigned treatment and will be regularly monitored through medical assessments, including imaging tests like CT scans or MRI, to track the progress of their disease. The study will also keep track of any side effects or adverse events that participants may experience during the trial. This information will help determine the safety and effectiveness of Epcoritamab compared to the standard chemotherapy options for treating relapsed or refractory DLBCL.

1 joining the trial

Upon joining the trial, the patient will be randomly assigned to receive either epcoritamab or a chemotherapy regimen chosen by the investigator.

The trial is designed to compare the effectiveness of epcoritamab against standard chemotherapy treatments for relapsed or refractory diffuse large B-cell lymphoma.

2 treatment administration

If assigned to the epcoritamab group, the patient will receive the medication as a subcutaneous injection. The frequency and dosage will be determined by the trial protocol.

If assigned to the chemotherapy group, the patient may receive a combination of medications such as rituximab, gemcitabine, and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). These medications are administered intravenously, and the specific regimen will be chosen by the investigator.

3 monitoring and assessments

Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular medical assessments and imaging tests to evaluate the size and activity of the lymphoma.

Blood tests and other laboratory evaluations will be conducted to monitor the patient’s overall health and detect any potential side effects from the treatment.

4 follow-up

After completing the treatment phase, the patient will enter a follow-up period. During this time, the patient’s health will continue to be monitored to assess the long-term effects of the treatment.

The follow-up period is crucial for understanding the duration of the treatment response and any delayed side effects.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must sign a form agreeing to participate in the trial and understanding its purpose and procedures.
  • Must have an ECOG PS score of 0-2, which is a way to measure how well you can perform daily activities.
  • Must have one of the specific types of B-cell lymphoma with CD20 positivity, which is a marker found on certain cancer cells.
  • Must have CD20 positivity confirmed by a tumor biopsy, which is a test to check for cancer cells.
  • Must have a type of lymphoma that has come back or not responded to treatment and have been treated with at least one type of cancer therapy before.
  • Must have either failed a previous stem cell transplant or not be eligible for one due to age, health, or other reasons.
  • Must have measurable disease, meaning the cancer can be seen and measured on scans like CT or MRI.
  • Must have a certain level of neutrophils, which are a type of white blood cell important for fighting infections.
  • Must have a certain level of platelets, which are cells that help with blood clotting.
  • If female, must agree not to donate eggs during the trial and for 12 months after the last treatment.
  • Must have liver enzyme levels within a certain range, unless the increase is due to specific conditions.
  • Must have a total bilirubin level within a certain range, unless the increase is due to specific conditions.
  • Must have a certain level of kidney function, measured by a test called eGFR.
  • Must have blood clotting times within a certain range, unless taking blood thinners.
  • If female and able to have children, must use effective birth control during the trial and for 12 months after the last treatment.
  • If female and able to have children, must have a negative pregnancy test before starting treatment and at the beginning of each treatment cycle.
  • If male and sexually active with a female who can have children, must use a condom and agree not to donate sperm during the trial and for 12 months after the last treatment.
  • Must have a life expectancy of more than 2 months with standard treatment.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than B-cell Lymphoma cannot participate. B-cell Lymphoma is a type of cancer that affects certain cells in the immune system.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific characteristics in participants.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Institut Jules Bordet Anderlecht Belgium
Orszagos Onkologiai Intezet Budapest Hungary
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitario Puerta Del Mar Cadiz Spain
Amphia Hospital Breda The Netherlands
St. Olavs Hospital HF Trondheim Norway
Hospital San Pedro De Alcantara Caceres Spain
AZ Turnhout Turnhout Belgium
Vitaz Sint-Niklaas Belgium
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Oulu University Hospital Oulu Finland
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
MD Anderson Cancer Center Madrid Spain
Roskilde University Roskilde Denmark
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Centre Henri Becquerel Rouen France
Pratia Hematologia Sp. z o.o. Katowice Poland
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Virgen del Rocío University Hospital Sevilla Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Karolinska University Hospital Solna Sweden
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Aalborg University Hospital Aalborg Denmark
Gasthuiszusters Antwerpen Antwerp Belgium
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Hospital Universitario Virgen De Valme Sevilla Spain
Centre Hospitalier De La Cote Basque Bayonne France
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Bravis Ziekenhuis Roosendaal The Netherlands
Centre Hospitalier Universitaire Amiens Picardie Amiens France
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hopital Beaujon Clichy France
Vrije Universiteit Brussel Jette Belgium
Universita Degli Studi Di Brescia Brescia Italy
Clinique Victor Hugo Le Mans France
University Of Szeged Szeged Hungary
Centre Hospitalier Universitaire De Caen Normandie Caen France
Cmwype Lcct Bzshnc Lyon France
Uoybffltgidihqdaunsme Ezwpg Akc Essen Germany
Oavzrzowzbbvwb Lgws Gqno Linz Austria
Rkighejld Zbcfalirwy Skkdwutwy Arnhem The Netherlands
Hxccaobo Uwbsbopwtfazf Mracvbi Dp Vibwtdilcv Santander Spain
Ivhditfn Ckkocz Ddpxqemjjedyidknb L'hospitalet De Llobregat Spain
Wqioplysyxe Wposjkjjkcsorcszpxqu Clfgoex Ogvpwteuz I Tjnmnyfathprr Io Mmxzvbucmui W Lkyjy Lodz Poland
Atattfws Do Rffwop Zwbqllxgza Bczh Goes The Netherlands
Ubvxdckewn Hibhmwsk Cvjypyj Cologne Germany
Cflryd Hepmtsdxdnt Ey Urvrilcylmpkl Ds Ldfsjxa Limoges France
Chaayv Hfazuwsmnmp Uvinqbzroqzqr Dg Dgqvp Dijon France
Iubmfmdq Rcuhkqrtd Pio Lt Ssknai Dcw Tecdwk Dvek Afhfalh Ihzj Shpmwy Meldola Italy
Awuhhqocdz Pswbqjsf Honndlbz Dk Mldstjwbw Marseille France
Hjbqbtxz Ukfauggfxc Ckzhvhd Hewvbfmd Helsinki Finland
Exfxtwv Unevcafbkxky Mytmntx Cexjqtv Rjxzkfrrn (ybofgxf Mtj Rotterdam The Netherlands
Atkezg Uqhlkxazhy Hlnapgmf Aarhus Denmark
Cejaqw Hywblmgugbi Riyjiaks Ugffebpmpduys Dm Tuzxu Tours France
Gifhqevhynvvjlvnh Vlnkisbhz Plqz Apaphm Etfxfjne Ofxzih Kfawfl Gyor Hungary
Aqlwvrv Obgdzenxnim Nvjgycsew Su Akkejrw E Bmtfrr E C Ajzuco Aqrisiraozs Alexandria Italy
Utbjrgruvn Oc Ahosave Edegem Belgium
Uxqibleliu Dphec Sxqfq Ds Rxbf Lw Srivduju Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.09.2020
Belgium Belgium
Not recruiting
01.09.2020
Denmark Denmark
Not recruiting
01.09.2020
Finland Finland
Not recruiting
01.09.2020
France France
Not recruiting
01.09.2020
Germany Germany
Not recruiting
01.09.2020
Hungary Hungary
Not recruiting
01.09.2020
Italy Italy
Not recruiting
01.09.2020
Norway Norway
Not recruiting
01.09.2020
Poland Poland
Not recruiting
01.09.2020
Spain Spain
Not recruiting
01.09.2020
Sweden Sweden
Not recruiting
01.09.2020
The Netherlands The Netherlands
Not recruiting
01.09.2020

Trial locations

Epcoritamab is a medication being tested in this clinical trial. It is used to treat patients with relapsed or refractory diffuse large B-cell lymphoma, a type of blood cancer. The trial aims to see how effective epcoritamab is compared to other standard treatments.

R-GemOx is a standard chemotherapy treatment used in this trial for comparison. It combines rituximab, gemcitabine, and oxaliplatin to help treat diffuse large B-cell lymphoma by targeting and killing cancer cells.

BR is another standard chemotherapy regimen used in the trial. It includes bendamustine and rituximab, which work together to treat diffuse large B-cell lymphoma by attacking the cancer cells and slowing their growth.

B-cell Lymphoma – B-cell lymphoma is a type of cancer that originates in the B cells, which are a type of white blood cell responsible for producing antibodies. This disease is characterized by the uncontrolled growth of these cells, leading to the formation of tumors in lymph nodes and other parts of the body. As the disease progresses, it can spread to other organs and tissues, disrupting their normal function. Symptoms may include swollen lymph nodes, fever, night sweats, and unexplained weight loss. The progression of B-cell lymphoma can vary, with some forms being more aggressive than others. The disease is considered rare and requires specialized medical attention for management.

Trial ID:
2023-504830-23-00
Protocol code:
GCT3013-05
Trial Phase:
Therapeutic confirmatory (Phase III)

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