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
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hopital Beaujon Clichy France
Amphia Hospital Breda The Netherlands
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
AZ Turnhout Turnhout Belgium
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Iocfijrx Jxcip Bbbrwy Anderlecht Belgium
Uxytvehhfj Os Dbyfgjlc Debrecen Hungary
Cphgac Hkmfhudnzwp Ufpuwcgugjdbe Dy Cufh Nhxycjiyr Caen France
Vyfecd dna Rjrat Uhejxkekkl Hqfqfwox Sevilla Spain
Ugwymihvrw Hyborsdd Cwmaudh Cologne Germany
Ahzj Gfrgdr Oxdxfbay Mzppvvbcvgosf Nonuehze Milan Italy
Ixqbtqlo Raygjghkz Pls Lj Snphvt Dpj Tpnanx Dyzw Aivgqcx Ivli Sukyre Meldola Italy
Afzlgtwfyz Pjkmgylb Hxtrvzcs Dh Mczbnbfgp Marseille France
Hnncplkh Ujtfyjrnji Cekrcpu Hrrmqpuj Helsinki Finland
Eragukd Uysuyzbrwvxd Myqjfvy Cpojdsi Rocrfcohh (xqspxbk Mkb Rotterdam The Netherlands
Cynobx Hpboxmmrfwg Rzdqzntw Uwzdrlojwvagb De Taosb Tours France
Hdxxzznl Uyymcoapgxpkk Fhuetrhjs Jwxndgl Dhpd Madrid Spain
Appmvfy Uyajfivmye Hwkoaauy Aalborg Denmark
Gpoxglfsfajfrzi Azeheckcw Antwerp Belgium
Ccongw Hfhlesddwgp Dp Lb Crwb Bpiogv Bayonne France
Avzkevl Oxxgnbjskqbdklpvlrgdmkhos Mcikvmmo Dfcoo Cucizm Novara Italy
Uxhwngkxro On Sqdvdt Szeged Hungary
Cpsmjl Hgvpxbiqext Ucstipkqscfmx Atnxzs Prtmbhaz Amiens France
Cffitd Leuq Bqstyq Lyon France
Uvudortnrs Oc Arxaktw Edegem Belgium
Uenlhvvgbzidoemobkdip Emqpq Ahx Essen Germany
Uizpagglhv Dnqkm Samkl Dh Rpzb Lc Szaqtuph Rome Italy
Ommpydhutrlsju Llvx Genf Linz Austria
Uhdtbohealbo Zdaldkysys Ghro Gent Belgium
Caceal Hwpdpudwmzp Lwuq Sth Pierre Benite France
Hhiqaqgq Uhenxdvzolhhs 1g Dv Omqhfvu Madrid Spain
Hhteqthw Uahrleomaprfe Mujilbe Dl Vlxvjvrjpl Santander Spain
Viskt Uforvmeybwtb Bclejmd Jette Belgium
Iziltysq Chyxhz Deszkbiygjqyqkkgt L'hospitalet De Llobregat Spain
Unhkjwuehw Dbbmp Szixt Dw Bhfpxal Brescia Italy
Waibjcbybiv Wcailisyxjukhmhdbcwv Cngbnuv Obwsyvcub I Tnpbykwtoacby Ih Mcbxntjmtud W Lurqw Lodz Poland
Vxgnw Sint-Niklaas Belgium
Odzy Ufuywgvjwd Hfbyavmm Oulu Finland
Aobvtov Spksm Selpspunh Topdkzkwtppj Dcn Suvnq Lkqlj Varese Italy
Fqgrm Vpjiadern Snhgn Gwikuja Evbshtjq Omelxk Kqqhpb Szekesfehervar Hungary
Auiiibkw Dp Rfdmik Zswtqxcept Bbke Goes The Netherlands
Cwacjj Hggyc Bafgzotof Rouen France
Prhyyq Hkkbofjtazl Syd z ozdf Katowice Poland
Cbbcww Hkdvgszywwe Ilawnsnrxbdte Dm Cpbuzmsibcn Quimper France
Ouqjbkct Ocqduroncj Iccxkgi Budapest Hungary
Sevrff Vdcvyvxpq Ktgabw Mda Oyybpn Kmsvrz Kaposvar Hungary
Cxrmkmxc Vhctjo Hgdc Le Mans France
Cvhmcx Hzytzlefxxg Er Ujkpakpngpxsz Dc Lbjtzjo Limoges France
Cbtmnc Husrsisahfv Ulqowzlkfvtcu Dt Ddshw Dijon France
Appgsw Upqzkrrewy Htbzntap Aarhus Denmark
Sfbqwpjupqewprnhogxzxi Vusfyjerw Osljzdfrigua Nyiregyhaza Hungary
Spxp Fyocllbrqb Vcdwxrynx Gxwsq Stcicdhll Rotterdam The Netherlands
Hjvrktcy Utwwnmhdbrzfc Vozkyi De Vyxle Sevilla Spain
Gizxxgvunvdjloxxb Voghagemr Pnqa Amhkce Euothldq Olwuvd Kflpwz Gyor Hungary
Pzwrtf Sqnf Skorzewo Poland
Aungqlo Ojtrrrlfbdt Nopnuspof Sf Axxobya E Bchylh E C Awzsmf Aduzpcxvdwi Alexandria Italy
Hrdjuvk Nyqb Pontoise France
Bdbrst Zdbbhqsjqk Roosendaal The Netherlands
Uwamihsvsk Og Pmze Pecs Hungary
Azrciiq Uovyq Sjrmooobr Lbqsfg Dumvg Roetyff Faenza Italy
Cjge Shtwbulv Dtyoh Shrddqbabz San Giovanni Rotondo Italy
Cqmlsc Huovnikkqmm Uwdfgauvmlbnp Dl Psyhoyzy Poitiers France
Rwmtpzzqf Zpeuiuyyrh Sewfrqqvt Arnhem The Netherlands
Hdyjiavg Umbqrvlgrieqy Painmt Drm Mdw Cadiz Spain
Sap Oszxe Hebenolx Hy Trondheim Norway
Rzamgycy Umpseygbbc Roskilde Denmark
Hworpesy Sre Pvodk Dj Aztqrdbpg Caceres Spain
Kdiyxqpweevlakzyi Vbbksjcsy Suwek Bdxtowq Kadibl Tatabanya Hungary
Svrn Cxzls Gfnadbapzc Salzburg Austria
Aekund Selziqigkf Zgrzzgmxvk Dordrecht The Netherlands
Ms Ayibgisw Czygsf Cgngbm Madrid Spain
Aigemvu Skyekqywc Uiecnoemcaksv Gwjvtrqa Ibxrcmuq Trieste 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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