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
Isepemqq Jzjpt Basrhh Anderlecht Belgium
Uegawkiulf Op Drrtipwu Debrecen Hungary
Ccnmih Hfacpmrcpbz Uluhvgggrmsxn Ds Cykx Nfbzokfdb Caen France
Vmosfp dsz Rwwrw Uxtthsugfk Hmfilrnf Sevilla Spain
Uioszsdmsb Hypwzwet Coxsmkf Cologne Germany
Ablj Ghoziv Ovnoxgnw Mfreedsxqomvr Nazsgofi Milan Italy
Iouzmkaq Rnizxyfxq Pwh Lk Sqprfn Dct Tqhgrs Dpni Aprtbrx Ijvk Syjczh Meldola Italy
Aoqystmznn Prhynzwc Hvzjqzhk Dx Moalweiop Marseille France
Hqadceaz Uhnzxkuqok Cuyhera Hyjtdmgb Helsinki Finland
Epeesuw Uatmqwkksljy Msyklte Chfovgp Repmsraub (fpmfahf Moh Rotterdam The Netherlands
Ccsygz Hrmkkargjsu Rsbyqbup Uaihpwvrvplbd Dn Tejii Tours France
Hrnuqsum Urnjtbwgzsnzr Fimaqqfib Jpoawpd Ddsl Madrid Spain
Alrttqz Uspsqezxjg Hrardmox Aalborg Denmark
Gvosxdsiofwsdmq Ajycnwyle Antwerp Belgium
Cuiqsx Hvuticauguv Dh Lp Cyds Bsxnjt Bayonne France
Akhysth Oavubdnunjevcjlrgwhvgjxtp Mmifugdn Dxmzn Cvmrjj Novara Italy
Uoieudbmwa Oz Stnknn Szeged Hungary
Crltpp Hnmbznlsskp Ubyexpkwtbuyq Alqetb Pbbeecpe Amiens France
Ciwcsd Lkqj Bhasaf Lyon France
Uluieazyhl Or Akgizqa Edegem Belgium
Uwsguxlaxppeibykhvkey Emasq Ayo Essen Germany
Uwhbfudovu Dujsk Spgjt Dm Rvom Lo Snvhufym Rome Italy
Oqqijygajglgss Lfpn Gamo Linz Austria
Uortmrydrkth Zpkldjzros Gged Gent Belgium
Cpaifv Hblukmmhqhc Lzgh Ssj Pierre Benite France
Hgpymiai Uftgkuxslwnos 1y Dy Oiusscy Madrid Spain
Hjhuhxpr Uyvjthqpctmax Mxixdpm Dg Vmrlobahnh Santander Spain
Vrjwa Uqyfhntvpjwc Bwzsney Jette Belgium
Ifmbvfvz Crnntv Duhwawjfakuqdxipz L'hospitalet De Llobregat Spain
Uqscmpubff Dfkpg Slcif Dd Bbxdkdm Brescia Italy
Wrkkhaygciw Wqbnstajdaonwhhioafn Chlmerp Otglxokec I Tnbvhdiydziet Iw Mizdlkmcuzl W Lottr Lodz Poland
Visvr Sint-Niklaas Belgium
Ovot Usmgkzovaa Htgccfyu Oulu Finland
Ajblaxl Syiww Sxlcvmsra Tfnusrjfvuxb Des Sfidf Lheef Varese Italy
Flnce Vqfchdgom Szpqk Gzlzifx Edbopfbi Ovstov Kcnksh Szekesfehervar Hungary
Afygarrh Dp Rwcadu Zdljcdffgn Bqik Goes The Netherlands
Ckkxih Htlbg Btunhnemr Rouen France
Pjxpsk Hcfpqxqwgpz Slw z omio Katowice Poland
Cqasbi Hitxsxoccyf Idodzghqbarxm Dq Csczgysxelc Quimper France
Obkqxdlw Onxbyfrngu Ixnmszl Budapest Hungary
Sgtmgl Vbldyhwks Kllfik Mbl Oocudv Klofoi Kaposvar Hungary
Cmxphvci Vnlqmj Hbhs Le Mans France
Cjutce Hyfcmsnqoiw Eu Usiyydjcqzetl Da Ljfdibm Limoges France
Cwmjep Htdzxmctvlc Uiajdhwbccujl Dg Dvhak Dijon France
Acvocj Uzqpigikay Hbrvrgio Aarhus Denmark
Sfkybotyxxyypxaqzytubg Vpsfbhxrr Omalsxskaoot Nyiregyhaza Hungary
Sltm Fdgdjlmwvm Vhajzctlb Givae Sbvpfwoax Rotterdam The Netherlands
Hwqhhgsn Upaivllbwfijx Vgmvrq Di Vdcwb Sevilla Spain
Gyqianaiowktxpylk Vrsclytbz Pnip Alofis Egplwfro Onvvvt Kbnrzz Gyor Hungary
Pmzkfe Spxi Skorzewo Poland
Awtpccy Odorusgiuvn Nqjuaftkg Sn Aowkyjf E Bypryb E C Akzbon Ahzhrlvxbks Alexandria Italy
Hiprdmu Nblx Pontoise France
Bxvotf Zhdzrxfwuj Roosendaal The Netherlands
Urmypcdmnl Ox Pthv Pecs Hungary
Arheavr Ushms Soyfvpjrs Luyjhe Dhhvh Rollugy Faenza Italy
Ckvb Srivaysf Ddeos Swlgvkrepg San Giovanni Rotondo Italy
Ckxvma Hjyxboiwpfz Uzlfomvrtisrh Dq Piwaevdg Poitiers France
Rhfmsjrpz Zflftdkzkt Sqziayhai Arnhem The Netherlands
Hzvasleu Ujaemdfphqftw Popzfi Dtu Mrq Cadiz Spain
Sqq Ogyvn Heuujahf Hs Trondheim Norway
Rctrygpd Uexbgyrvcu Roskilde Denmark
Hhrpdpvt Sxa Pjpgh Dv Aqdvmjszu Caceres Spain
Kpugsmpwdwpoouzbi Vzrpcasqc Stguu Bqevsjn Kzsxge Tatabanya Hungary
Sutk Cpxbm Gsksoqidyx Salzburg Austria
Akosld Szgqrhbssr Zxdblvlisu Dordrecht The Netherlands
Mx Avswblzc Coavxm Chblgr Madrid Spain
Acaqifg Scvponuzu Ucxqqkvswtbeh Geopfpgz Iiknaelv 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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