Study Comparing Epcoritamab and Lenalidomide with a Drug Combination for Adults with Relapsed or Refractory Diffuse Large 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 form of non-Hodgkin lymphoma. The study is specifically for patients whose DLBCL has returned or has not responded to previous treatments. The trial will compare two different treatment combinations. One group will receive a combination of Epcoritamab, a type of medication known as a bispecific antibody, and Lenalidomide, which is taken orally in capsule form. The other group will receive a combination of Rituximab, Gemcitabine, and Oxaliplatin, all of which are given through intravenous infusion.

The purpose of this study is to determine if the combination of Epcoritamab and Lenalidomide can improve the time patients live without their disease getting worse, compared to the combination of Rituximab, Gemcitabine, and Oxaliplatin. Participants will be randomly assigned to one of the two treatment groups. The study will involve regular visits to the clinic for treatment and monitoring, which will include various tests and assessments to track the progress of the disease and the effects of the treatment.

Throughout the study, participants will receive either the active treatment or a placebo, depending on the group they are assigned to. The trial will continue for a set period, during which the health and response to treatment of the participants will be closely monitored by the medical team. The study aims to provide valuable information that could lead to better treatment options for patients with relapsed or refractory DLBCL.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility is based on having a specific type of lymphoma and previous treatment history.

2 treatment group assignment

Participants are randomly assigned to one of two treatment groups: one receiving epcoritamab plus lenalidomide, and the other receiving rituximab plus gemcitabine and oxaliplatin.

3 treatment administration

For the epcoritamab and lenalidomide group: Epcoritamab is administered as a subcutaneous injection. Lenalidomide is taken orally in capsule form.

For the rituximab, gemcitabine, and oxaliplatin group: Rituximab, gemcitabine, and oxaliplatin are administered through intravenous infusion.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment. This includes medical examinations and imaging tests.

The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the disease does not worsen.

5 completion of treatment

Upon completion of the treatment phase, further assessments are conducted to determine the overall response and any potential side effects.

Participants may continue to be monitored for overall survival and other health outcomes.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL), which is a type of blood cancer. This includes specific subtypes like DLBCL with certain genetic changes, and other related lymphomas.
  • The patient must have relapsed (cancer returned after treatment) or refractory (cancer did not respond to treatment) disease and have been treated with at least one type of cancer therapy that includes a specific antibody treatment.
  • The patient must meet at least one of the following conditions:
    • Failed a previous Autologous Stem Cell Transplant (ASCT), meaning the cancer returned or did not respond after the transplant.
    • Not suitable for ASCT due to age, health status, other health issues, or insufficient response to previous treatment, or have refused ASCT.
    • Ineligible for or unable to receive CAR-T therapy, which is a type of treatment that uses the patient’s own modified immune cells, due to reasons like health, inability to collect enough immune cells, unwillingness, or issues related to cost, location, insurance, or manufacturing.
    • Relapsed or progressed after achieving at least a partial or complete response with previous CAR-T therapy.
  • The patient must have measurable disease, meaning there is at least one tumor that can be measured by a scan, and it shows up on a specific type of imaging test called a PET scan.
  • The patient must have a performance status score between 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well the patient can perform daily activities.
  • The patient must be an adult, as the study includes both male and female participants.

Who Cannot Join the Study?

  • Patients who have a different type of cancer other than Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. This means the study is only for those with this specific type of lymphoma that has returned or not responded to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements that must be met.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible to participate.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate. This means you need to be able to commit to the study schedule.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot join the study. This is to ensure the safety of all participants.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Centre Hospitalier Epicura Ath Belgium
Frisius Heerenveen The Netherlands
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
KBC Zagreb Zagreb Croatia
Orszagos Onkologiai Intezet Budapest Hungary
Centre Hospitalier Universitaire De Poitiers Poitiers France
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Algemeen Ziekenhuis Delta Roeselare Belgium
University Hospital St Marina Varna Varna Bulgaria
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Centre Hospitalier D Avignon Avignon France
University Of Debrecen Debrecen Hungary
Spitalul Clinic Coltea Bucharest Romania
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
National Specialised Hospital For Active Treatment Of Haematological Diseases Sofia Bulgaria
Clinical Medical Center Osijek Osijek Croatia
Institutul Regional De Oncologie Iasi Iasi Romania
Hospital Da Luz S.A. Lisbon Portugal
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Semmelweis University Budapest Hungary
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Centre Hospitalier De La Cote Basque Bayonne France
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
University Hospital Olomouc Olomouc Czechia
University Of Pecs Pecs Hungary
KBC Split Split Croatia
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire De Caen Normandie Caen France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
University Hospital Merkur Zagreb Croatia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Fundeni Clinical Institute Bucharest Romania
Tlqvigdfpl Cpbdkj Hfjupfpt Thessaloniki Greece
Lsnqt Gsyctrg Hdpyscho Ot Aufcdg Athens Greece
Kbasihff bguvnbte cbhbdv Rexgvc (riyzyhwf Hmwqugzw Crovfa Rgpicme Rijeka Croatia
Aifmsmh Sgj z ofgj Poznan Poland
Fpajjxea nsedpycfw Mqvtr a Hshfjtz Prague Czechia
Csnahz Hndgpgtuung Ryntvdno Uqzzubxlozmng Dt Twazb Tours France
Ulg Mqoodbszvswg Yvoir Belgium
Gcutbpuswltsywvva Vjymkfwhk Pvpy Aufxlv Enuxvupn Oettvg Kjujvj Gyor Hungary
Nbypuzrs Iybifyex Ochmqozyf Ixw Mqkpp Sxulyedrqaxruscpitjgdbhyehsh Icudhajf Bqdhvlcg Cracow Poland
Euphboxosemamwynfnxorulflc Htsboqgg oc Ajuboq Athens Greece
Hycjirza Ukurchlozpsija Sksxiyotlt &eoduga Hdlcxtk dv Hilxpmtpkau STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
16.08.2024
Bulgaria Bulgaria
Not recruiting
16.08.2024
Croatia Croatia
Not recruiting
16.08.2024
Czechia Czechia
Not recruiting
16.08.2024
France France
Not recruiting
16.08.2024
Greece Greece
Not recruiting
16.08.2024
Hungary Hungary
Not recruiting
16.08.2024
Poland Poland
Not recruiting
16.08.2024
Portugal Portugal
Not recruiting
16.08.2024
Romania Romania
Not recruiting
16.08.2024
The Netherlands The Netherlands
Not recruiting
16.08.2024

Trial locations

Epcoritamab is a medication being studied for its potential to help treat diffuse large B-cell lymphoma, a type of blood cancer. It is being tested in combination with another drug to see if it can improve patient outcomes.

Lenalidomide is a medication that is often used to treat certain types of blood cancers. In this study, it is combined with epcoritamab to see if the combination can be more effective in treating diffuse large B-cell lymphoma.

Rituximab is a medication that targets specific cells in the immune system and is commonly used to treat certain types of blood cancers, including diffuse large B-cell lymphoma. In this trial, it is used in combination with other drugs to compare its effectiveness against the new treatment being studied.

Gemcitabine is a chemotherapy drug that is used to treat various types of cancer. In this study, it is combined with rituximab and another drug to evaluate its effectiveness in treating diffuse large B-cell lymphoma.

Oxaliplatin is a chemotherapy medication used to treat cancer. It is part of the combination therapy with rituximab and gemcitabine in this trial, and its role is to help kill cancer cells in patients with diffuse large B-cell lymphoma.

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma, which is a cancer that originates in the lymphatic system. It primarily affects B-cells, a type of white blood cell that plays a crucial role in the immune response. DLBCL is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. The disease can be aggressive, leading to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. Relapsed or refractory DLBCL refers to cases where the disease returns after treatment or does not respond to initial therapy. The progression of DLBCL can vary, with some cases responding well to treatment while others may require more intensive management.

Trial ID:
2024-510965-41-00
Protocol code:
M22-128
Trial Phase:
Therapeutic confirmatory (Phase III)

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