Study on Epcoritamab, Rituximab, and Lenalidomide for Adults with Untreated Follicular Lymphoma

3 1 1 1

What is this study about?

This clinical trial is focused on studying a type of cancer called Follicular Lymphoma, which is a form of non-Hodgkin lymphoma. The study is investigating the effectiveness and safety of a new treatment combination for patients who have not received any prior treatment for this condition. The treatment being tested includes a combination of three medications: Epcoritamab, Rituximab, and Lenalidomide. Epcoritamab is a type of medication known as a bispecific antibody, which is designed to help the immune system target and destroy cancer cells. Rituximab is a chimeric monoclonal antibody that also helps the immune system attack cancer cells, while Lenalidomide is a medication that affects the immune system and has anti-cancer properties.

The purpose of this study is to determine if the combination of Epcoritamab, Rituximab, and Lenalidomide can improve the rate of complete response, meaning the disappearance of all signs of cancer, compared to the standard treatment known as chemoimmunotherapy. Participants in the study will be randomly assigned to receive either the new combination treatment or the standard treatment. The study will monitor participants over a period of time to assess the safety of the treatments and any changes in the activity of the disease. The study will also look at other outcomes, such as progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time from the start of treatment that patients are still alive.

Throughout the study, participants will receive their treatments either through subcutaneous injection, which is an injection under the skin, or intravenous infusion, which is an injection into a vein, depending on the medication. The study aims to provide valuable information on whether this new combination of treatments can offer a better outcome for patients with previously untreated Follicular Lymphoma compared to existing treatment options. Participants will be closely monitored for any adverse events, which are any unwanted effects of the treatment, to ensure their safety throughout the study.

1 initial treatment phase

The trial begins with the administration of epcoritamab through a subcutaneous injection. This is combined with rituximab and lenalidomide. Rituximab is given intravenously, while lenalidomide is taken orally in capsule form.

The purpose of this phase is to assess the initial response to the combination of these medications.

2 treatment continuation

The treatment continues with regular doses of the same medications: epcoritamab, rituximab, and lenalidomide. The frequency and dosage are determined by the study protocol and the patient’s response to the treatment.

This phase aims to maintain the response and monitor any changes in the disease activity.

3 monitoring and assessment

Throughout the trial, regular assessments are conducted to monitor the patient’s health and the effectiveness of the treatment. This includes imaging tests like PET-CT scans to evaluate the disease status.

The primary goal is to achieve a complete response at 30 months, as measured by these assessments.

4 completion of trial

The trial concludes after the specified duration, which is estimated to be around 30 months. The final assessments are conducted to determine the overall effectiveness of the treatment.

The results are compared to those of patients receiving standard chemoimmunotherapy to evaluate the benefits of the new treatment regimen.

Who Can Join the Study?

  • Have a diagnosis of follicular lymphoma (FL), which is a type of blood cancer.
  • Have a specific type of FL called CD20+, confirmed by a recent tumor biopsy. This means the cancer cells have a certain marker called CD20.
  • Be willing and able to follow the procedures required in the study.
  • Have cancer that is at stage III or IV, or stage II with a large tumor (at least 7 cm in diameter).
  • Need treatment according to the study doctor, based on certain criteria for FL.
  • Have one or more target lesions, which are areas of cancer that can be seen on scans. This includes:
    • A PET/CT scan showing a positive lesion, which means the cancer is active.
    • At least one measurable lymph node larger than 1.5 cm or one measurable area outside the lymph nodes larger than 1.0 cm on a CT scan or MRI.
  • Have an ECOG performance status of 0 to 2, which is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means able to do some activities but not work.
  • Be eligible to receive one of the standard treatments: chemoimmunotherapy or a combination of rituximab and lenalidomide.

Who Cannot Join the Study?

  • Patients who have already received treatment for Follicular Lymphoma cannot participate. Follicular Lymphoma is a type of cancer that affects the lymphatic system, which is part of the body’s 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 part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients with other medical conditions that might interfere with the study or make it unsafe for them to participate cannot join the study.

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
IRCCS Humanitas Research Hospital Rozzano Italy
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
KBC Zagreb Zagreb Croatia
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Orszagos Onkologiai Intezet Budapest Hungary
Staedtisches Klinikum Karlsruhe gGmbH Karlsruhe Germany
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Klina Brasschaat Belgium
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Hospital De Santa Maria E.P.E. Lisbon Portugal
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Algemeen Ziekenhuis Delta Roeselare Belgium
Tokuda Hospital Sofia Bulgaria
Hospital San Pedro De Alcantara Caceres Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
MD Anderson Cancer Center Madrid Spain
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen Boras Sweden
Centre Hospitalier D Avignon Avignon France
Evangelismos S.A. Athens Greece
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Spitalul Clinic Coltea Bucharest Romania
Opca Bolnica Zadar Zadar Croatia
Groupe D’Etude Des Lymphomes De L’Adulte Pierre Benite France
Institutul Regional De Oncologie Iasi Iasi Romania
Odense University Hospital Odense Denmark
Universita’ Campus Bio-medico Di Roma Rome Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Le Mans Le Mans France
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Champalimaud Clinical Centre Lisbon Portugal
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Klinikum Kassel GmbH Kassel Germany
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
CHC MontLegia Liege Belgium
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Bravis Ziekenhuis Roosendaal The Netherlands
Region Midtjylland Aarhus Denmark
Hopital Prive D Antony Antony France
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Rigshospitalet Copenhagen Denmark
KBC Split Split Croatia
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Region Sjaelland Holbæk Denmark
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Prive Du Confluent Nantes France
Specialized Hospital For Active Treatment Of Hematological Diseases EAD Sofia Bulgaria
Olympion Therapeftirio General Clinic Of Patras S.A. Patras Greece
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Fundeni Clinical Institute Bucharest Romania
Cryjwnngk Ucvilazbmttgsl Sbswuxyuz Woluwe-Saint-Lambert Belgium
Nbuarsmb Oeykfyar Idwqewkin Bratislava Slovakia
Lhjoe Ucazofcvrioc Mwledau Cnzcqfb (iaapf Leiden The Netherlands
Rpevqtxtr Zlxwezfjag Snjicarhb Arnhem The Netherlands
Ugzfbtyomrbl Mimgubm Cikqkzk Gvzdgwdhj Groningen The Netherlands
Hsltzmdq Ueopzqahmjpni Mdvxegt Dy Vnovebiued Santander Spain
Ikrxnfcu Caqrhb Dfyqjgbukgpreolne L'hospitalet De Llobregat Spain
Wlmxeudjnym Wxowtnsskojmkilahkmr Cnajxfp Olndugqff I Tgezlvwasgroi In Mnyvbqcxnen W Lgqmf Lodz Poland
Sumyscokpwmgpbotxhddf gzpff Eschweiler Germany
Jfhtvswcy Meskoga Sznsxw Ceihlfny Upgvmwkdyf Martin Slovakia
Lwcbq Gumplbi Hsnujmyy Op Azomma Athens Greece
Afxegvk Obwxtrnflgo Oxypencu Rymuear Vwyrl Svfyd Chfbzgfa Palermo Italy
Cisaht dt Ryebhtrntvtod &yooawx Cyzujcgo Sshxac Ayud STRASBOURG, Alsace France
Kpopxjud bzgdrzky cmlpvh Rnvgok (syqjjpcf Hkiawchv Cygiet Rwnepbp Rijeka Croatia
Absgojq Snx z opdy Poznan Poland
Abgsndezwb Pyeqkfgj Hztitirv Dh Pfrxv Paris France
Sqx Espaglzss Hhanbkfw Txpprjt Tilburg The Netherlands
Gamfovvevyxgvnemf Vqvoofbbx Poyn Afwasw Esttzolp Ojvtmb Kfdrcu Gyor Hungary
Njepwnmc Imkjqqws Ohthmfdhd Iud Mednb Scescqlavfrekbytrfcmoibdqprn Igdcndmo Bwaakotj Cracow Poland
Gunpkq Ubjbdkllix Fwglsreyo Frankfurt Germany
Aptogyd Uca Icrmq De Rihdnz Elvkzr Reggio Emilia Italy
Aehzglu Uadnd Smhfbspkv Lhhznc Do Bxbbdbd Bologna Italy
Hlyzgwcl Dj Lz Sibva Cabm I Smeg Pjz Barcelona Spain
Ukwwrixqpc Ot Akslmlf Edegem Belgium
Hivikwrt Vucn dkffjdhh Barcelona Spain
Cucprraw Htwhblfr Dmxvubt Zagreb Croatia
Uyaixzgarg Gahquap Hgscfakz Abdsdvq Athens Greece

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
01.05.2024
Bulgaria Bulgaria
Not recruiting
01.05.2024
Croatia Croatia
Not recruiting
01.05.2024
Czechia Czechia
Not recruiting
01.05.2024
Denmark Denmark
Not recruiting
01.05.2024
France France
Not recruiting
01.05.2024
Germany Germany
Not recruiting
01.05.2024
Greece Greece
Not recruiting
01.05.2024
Hungary Hungary
Not recruiting
01.05.2024
Italy Italy
Not recruiting
01.05.2024
Poland Poland
Not recruiting
01.05.2024
Portugal Portugal
Not recruiting
01.05.2024
Romania Romania
Not recruiting
01.05.2024
Slovakia Slovakia
Not recruiting
01.05.2024
Spain Spain
Not recruiting
01.05.2024
Sweden Sweden
Not recruiting
01.05.2024
The Netherlands The Netherlands
Not recruiting
01.05.2024

Trial locations

Epcoritamab is a medication being studied for its potential to treat follicular lymphoma. It is designed to help the body’s immune system target and destroy cancer cells. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients who have not been treated for this type of cancer before.

Rituximab is a medication that is commonly used to treat certain types of cancer, including follicular lymphoma. It works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and attack these cells. In this trial, rituximab is used in combination with other treatments to evaluate its effectiveness in improving patient outcomes.

Lenalidomide is a medication that helps the immune system fight cancer by affecting the growth of cancer cells and enhancing the body’s immune response. It is often used in combination with other drugs to treat various types of cancer, including follicular lymphoma. In this study, lenalidomide is part of the treatment regimen being tested to determine its impact on the disease.

Investigated diseases:

Follicular Lymphoma – Follicular Lymphoma is a type of non-Hodgkin lymphoma that typically grows slowly and affects the lymphatic system. It originates from B-lymphocytes, a type of white blood cell, and often presents as painless swelling in the lymph nodes. Over time, the disease can spread to other parts of the body, including the bone marrow and spleen. Patients may experience symptoms such as fatigue, night sweats, and weight loss. The progression of Follicular Lymphoma can vary, with periods of stability followed by phases of more rapid growth.

Trial ID:
2023-506906-38-00
Protocol code:
M22-003
Trial Phase:
Therapeutic confirmatory (Phase III)

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