Study on Venetoclax and Epcoritamab for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying treatments for two types of blood cancers: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are conditions where the body produces too many abnormal white blood cells, which can crowd out healthy cells and lead to various health issues. The study is testing a combination of two treatments: Venetoclax, which is taken as a film-coated tablet, and Epcoritamab (GEN3013), which is given as an injection under the skin. Venetoclax works by helping to kill cancer cells, while Epcoritamab is a type of protein that helps the immune system target and destroy cancer cells.

The purpose of this study is to find out how effective these treatments are when used together in patients whose CLL or SLL has returned or has not responded to previous treatments. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of Epcoritamab to use with Venetoclax. In the second phase, they will evaluate how well the combination works in reducing the number of cancer cells in the bone marrow, which is the soft tissue inside bones where blood cells are made.

Participants in the study will receive Venetoclax for 26 cycles, which are periods of treatment, along with either 6 or 12 cycles of Epcoritamab. The study will monitor the participants’ health and the effects of the treatment over time. The goal is to see if the combination can help achieve a state where cancer cells are no longer detectable in the bone marrow, which is a sign of effective treatment. The study will also look at how long participants remain free from disease progression and their overall survival during and after the treatment.

1 initial treatment phase

Upon joining the study, you will begin the initial treatment phase. This involves taking the medication venetoclax, which is provided in the form of a film-coated tablet. You will take this medication orally.

The dosage and frequency of venetoclax will be determined by the study team based on your specific needs and the phase of the trial you are in. This phase is designed to help determine the best dose for the next part of the trial.

2 combination treatment phase

In this phase, you will continue taking venetoclax and will also receive epcoritamab. Epcoritamab is administered as a solution for injection under the skin, known as a subcutaneous injection.

The combination treatment is given in cycles. You will receive epcoritamab for either 6 or 12 cycles, depending on the group you are assigned to. Each cycle lasts for a specific period, and the study team will provide detailed instructions on the schedule.

3 monitoring and follow-up

Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular visits to the study site for assessments and tests to check the effectiveness of the treatment and any side effects.

After completing the treatment cycles, follow-up visits will continue to monitor your condition. These visits will occur every 3 months for the first year, then every 6 months until relapse or up to 6 years after starting the trial.

Who Can Join the Study?

Must have a documented case of relapsed (came back after treatment) or refractory (did not respond to treatment) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). SLL is only for the second part of the study.
Must have tested negative for hepatitis B and hepatitis C viruses. If previously tested positive, a negative PCR test is required within 6 weeks before joining the study.
Must be able and willing to follow the study visit schedule and other study requirements.
Must be able to give informed consent, which means understanding the study and agreeing to participate.
Must provide written informed consent.
Must need treatment according to specific medical guidelines for CLL.
Must be at least 18 years old.
Must have an ECOG/WHO performance status of 0-2, which means being fully active or having some restrictions but able to carry out light work.
If previously treated with venetoclax, must have finished treatment at least 24 months ago and not have had disease progression during that treatment.
Must have adequate bone marrow function, which includes:
- Hemoglobin levels above 9 g/dL, unless low levels are due to CLL/SLL affecting the bone marrow.
- Neutrophil count above 1,000/μL, unless low levels are due to CLL/SLL affecting the bone marrow.
- Platelet count above 30,000/μL, unless low levels are due to CLL/SLL affecting the bone marrow.
Must have an estimated Glomerular Filtration Rate (eGFR) or creatinine clearance of at least 50 ml/min, which indicates kidney function.
Must have adequate liver function, shown by:
- Levels of liver enzymes (ASAT and ALAT) no more than 3 times the upper limit of normal.
- Bilirubin levels no more than 1.5 times the upper limit of normal, unless due to specific conditions like Gilbert’s syndrome.
Must have prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than 1.5 times the upper limit of normal, unless on blood thinners.

Who Cannot Join the Study?

Patients with other types of cancer that are not Small Lymphocytic Lymphoma or Chronic Lymphocytic Leukemia cannot participate.
Patients who have not relapsed or whose disease is not resistant to treatment cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with certain medical conditions that could interfere with the study cannot participate.
Patients who are taking medications that could interfere with the study cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with a history of severe allergic reactions to the study medications cannot participate.
Patients with active infections or other serious health issues that could affect their safety during the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Frisius	Heerenveen	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Ziekenhuis Gelderse Vallei Stichting	Ede	The Netherlands
Haga Hospital	Hague	The Netherlands
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie	Munster	Germany
Meander Medical Center	Amersfoort	The Netherlands
Aalborg University Hospital	Aalborg	Denmark
Gasthuiszusters Antwerpen	Antwerp	Belgium
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Rigshospitalet	Copenhagen	Denmark
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Jeroen Bosch Ziekenhuis Stichting	s-Hertogenbosch	The Netherlands
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Odense University Hospital	Odense	Denmark
Abbmkfogk Ujd	Amsterdam	The Netherlands
Shp Ezkommtxu Hbvrxhjg Tovxmmb	Tilburg	The Netherlands
Mkzsutccyspalsdihirbksxctw Hfqnclfvtqkemycz	Halle (Saale)	Germany
Ucsixjssie Hdrefovk Cvfgxqe	Cologne	Germany
Ujwwmgqlgfzp Megkhrg Cndzqpz Gpixysbkh	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.12.2023
Denmark	Recruiting	01.12.2023
Germany	Recruiting	01.12.2023
The Netherlands	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Venetoclax is a medication used in this clinical trial to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or has not responded to previous treatments. It works by targeting and blocking a specific protein in cancer cells that helps them survive. By blocking this protein, venetoclax can help kill the cancer cells and reduce the size of the tumors.

Epcoritamab is another medication being tested in this trial. It is used in combination with venetoclax to treat patients with relapsed or refractory CLL or SLL. Epcoritamab is designed to help the immune system recognize and attack cancer cells. It works by binding to specific proteins on the surface of the cancer cells and immune cells, bringing them together so that the immune cells can destroy the cancer cells more effectively.

Small Lymphocytic Lymphoma – Small Lymphocytic Lymphoma (SLL) is a type of non-Hodgkin lymphoma characterized by the presence of small, mature-appearing lymphocytes. It primarily affects the lymph nodes and is closely related to Chronic Lymphocytic Leukemia (CLL), differing mainly in the location of the cancer cells. In SLL, the cancer cells are mostly found in the lymph nodes, whereas in CLL, they are primarily in the blood and bone marrow. The disease progresses slowly, often over many years, and may not cause symptoms initially. As it advances, it can lead to swollen lymph nodes, fatigue, and an increased risk of infections. Over time, the disease may spread to other parts of the body, including the liver and spleen.

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal lymphocytes. These cancerous cells accumulate in the blood and bone marrow, crowding out healthy blood cells. CLL progresses slowly and may not cause symptoms for a long time. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. The accumulation of cancerous cells can also cause anemia and bleeding problems. Over time, CLL may spread to other organs, including the liver and spleen.

Trial ID:

2022-500305-40-00

Protocol code:

HO165

NCT ID:

NCT05791409

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Venetoclax and Epcoritamab for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?