Study on the Safety and Effectiveness of Epcoritamab, Venetoclax, and Lenalidomide for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a treatment for people with Chronic Lymphocytic Leukemia (CLL) and Richter’s Syndrome. The treatment being tested is called Epcoritamab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific targets in the body, such as cancer cells. In this study, Epcoritamab is being tested alone and in combination with other medications, including Venetoclax and Lenalidomide. Venetoclax is a medication that helps to kill cancer cells by blocking a protein that allows them to survive, while Lenalidomide is used to help the immune system attack cancer cells.

The purpose of the study is to find the best dose of Epcoritamab and to see how well it works in treating these conditions. Participants will receive Epcoritamab either by itself or in combination with Venetoclax or Lenalidomide, depending on their specific condition. The study will also look at how safe the treatment is and how well it is tolerated by participants. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will be monitored closely to assess the treatment’s effects on their condition and any side effects they may experience. The study aims to provide valuable information on the potential benefits and risks of using Epcoritamab for treating Chronic Lymphocytic Leukemia and Richter’s Syndrome. This research could lead to new treatment options for people with these challenging conditions.

1 initial treatment phase

The study begins with the administration of epcoritamab as a monotherapy. This involves receiving the medication through a subcutaneous injection. The goal is to determine the appropriate dosage and assess safety.

During this phase, the frequency and duration of administration will be determined based on individual response and tolerance.

2 combination therapy with venetoclax

Following the initial phase, epcoritamab is combined with venetoclax, which is taken orally. The dosage of venetoclax is 400 mg.

The combination aims to evaluate the safety and effectiveness of the two medications together. The duration of this phase depends on the response to treatment.

3 expansion therapy with lenalidomide

For patients with Richter’s Syndrome, epcoritamab is combined with lenalidomide. This phase assesses the preliminary effects of the combination.

Lenalidomide is administered orally, and the treatment continues as long as it is deemed beneficial.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatments. This includes routine blood tests and imaging studies.

Follow-up visits are scheduled to track progress and manage any side effects that may occur.

Who Can Join the Study?

The person must sign an informed consent form before any screening procedures.
The person must be at least 18 years old.
The person must have an ECOG performance status score of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities.
There must be evidence of CD20 positivity in a sample that represents the disease, such as a tumor biopsy, blood sample, or bone marrow sample.
The person must have acceptable laboratory test results.
A woman who can have children must agree to use effective birth control during the trial and for 12 months after the last dose of the study drug.
A woman who can have children must have a negative pregnancy test before starting the trial and before each treatment cycle.
A woman must agree not to donate eggs for assisted reproduction during the trial and for 12 months after the last treatment.
A man who is sexually active with a woman who can have children and has not had a vasectomy must agree to use a barrier method of birth control, like a condom.
For those with R/R CLL (a type of leukemia), the person must have active disease that needs treatment and must have received at least two prior treatments.
The person must have a diagnosis of CLL/SLL that meets specific criteria.
The person must take preventive measures for TLS (tumor lysis syndrome), a condition that can occur when cancer cells break down quickly.
For those with Richter’s Syndrome, the person must have measurable disease as determined by specific scans and must provide a required tumor tissue sample.
For those eligible for Lenalidomide Combination Therapy, the person must have a specific type of tumor and a history of CLL/SLL, be ineligible for certain other treatments, and be eligible for lenalidomide.
For those eligible for R-CHOP Combination Therapy, the person must have a specific type of tumor and a history of CLL/SLL and be eligible to receive R-CHOP treatment.
For those eligible for Venetoclax Combination Therapy, the person must have active CLL/SLL disease that needs treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer than Chronic Lymphocytic Leukemia (CLL) cannot participate. CLL is a type of cancer that affects the blood and bone marrow.
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 able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients who have allergies or reactions to the study medication or similar medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Odense University Hospital	Odense	Denmark
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Pratia S.A.	Skorzewo	Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Rigshospitalet	Copenhagen	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
University Hospital Ostrava	Ostrava	Czechia
L’Hopital Prive Du Confluent	Nantes	France
Zealand University Hospital	Roskilde	Denmark
Uqupmkizsfdb Mamgxrq Cehhkak Gqhxbzxtt	Groningen	The Netherlands
Iltotddt Ctkurm Dohbvdtwuzophbgnb	L'hospitalet De Llobregat	Spain
Aoxffbb Sim z oocb	Poznan	Poland
Uhsllnfthe Hbccixpz Cwsdqay	Cologne	Germany
Iyrlodlp Rxbizembg Pmx Lg Skmxjz Dzh Thtzfz Ddgp Asnesex Ikov Suuygo	Meldola	Italy
Aasxhfljd Uue	Amsterdam	The Netherlands
Apghik Uwykxbkgvk Htojgshg	Aarhus	Denmark
Awsflap Obtutxwlukz Udgxdkzkmgono Cwcrfstrijsf Dbseh Srehrx E Ddyhs Scciosv Dc Tomxdl	Turin	Italy
Cqrs Da Nibnn	Vandoeuvre Les Nancy	France
Avhtfie Uqoqv Shskuizmn Lxszea Df Brvnmyj	Bologna	Italy
Hsfymvns Db Lj Smmjl Cuan I Sfqj Peh	Barcelona	Spain
Ulzdiztmbz Dwbwl Syjzd Dr Rvbh Ly Sizaejqj	Rome	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	25.11.2020
Czechia	Not recruiting	25.11.2020
Denmark	Not recruiting	25.11.2020
France	Not recruiting	25.11.2020
Germany	Not recruiting	25.11.2020
Italy	Not recruiting	25.11.2020
Poland	Not recruiting	25.11.2020
Spain	Not recruiting	25.11.2020
The Netherlands	Not recruiting	25.11.2020

Trial locations

Investigated drugs:

Epcoritamab is a medication being studied for its potential to treat certain types of blood cancers, specifically relapsed or refractory chronic lymphocytic leukemia (R/R CLL) and Richter’s syndrome (RS). It is designed to help the immune system target and destroy cancer cells. The trial aims to find the best dose of epcoritamab and to evaluate its safety and effectiveness when used alone or in combination with other treatments.

Venetoclax is another medication involved in the trial, used in combination with epcoritamab for treating R/R CLL. Venetoclax works by helping to kill cancer cells and is being tested to see how well it works with epcoritamab to improve treatment outcomes.

Lenalidomide is being tested in combination with epcoritamab for treating Richter’s syndrome. Lenalidomide is known to modify the immune system and may help enhance the effects of epcoritamab in fighting cancer cells.

R-CHOP is a combination therapy that includes several drugs used to treat certain types of lymphoma. In this trial, R-CHOP is combined with epcoritamab to assess its effectiveness in treating Richter’s syndrome. The goal is to see if adding epcoritamab can improve the treatment results of the standard R-CHOP regimen.

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow. It is characterized by the production of an excessive number of abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. CLL typically progresses slowly, and many individuals may not experience symptoms for years. As the disease advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression of CLL can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Trial ID:

2023-504828-25-00

Protocol code:

GCT3013-03

NCT ID:

NCT04623541

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Epcoritamab, Venetoclax, and Lenalidomide for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?