Study of Tazemetostat with R-CHOP for Newly Diagnosed Diffuse Large B Cell Lymphoma or High-Risk Follicular Lymphoma Patients

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What is this study about?

This clinical trial is focused on studying two types of blood cancers: Diffuse Large B Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). The study involves a treatment regimen known as R-CHOP, which includes several medications: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone. Additionally, a new medication called Tazemetostat (also known by its code name EPZ-6438) is being tested. The purpose of the study is to determine the best dose of Tazemetostat when used with R-CHOP and to assess how well this combination works in treating these cancers.

Participants in the study will receive the treatment over several cycles. Each cycle involves taking the medications in a specific order and at specific times. The study will monitor how the body responds to the treatment and any side effects that may occur. The goal is to see if the treatment can lead to a complete response, meaning the cancer is no longer detectable at the end of the treatment period.

The study is divided into two phases. The first phase aims to find the most effective dose of Tazemetostat, while the second phase focuses on evaluating the treatment’s success in achieving a complete response in patients. The study will continue until the end of 2026, with the hope of providing valuable information on improving treatment options for patients with DLBCL and FL.

1 initial treatment phase

The treatment begins with the administration of cyclophosphamide, doxorubicin, vincristine, and rituximab through an intravenous infusion. This combination is part of the R-CHOP regimen.

The prednisolone is taken orally. This phase is repeated every 21 days for a total of 6 cycles.

2 tazemetostat administration

After completing the 6 cycles of R-CHOP, tazemetostat is introduced. It is taken orally.

This phase includes 2 cycles of tazemetostat and rituximab administered through an intravenous infusion.

3 monitoring and assessment

Throughout the treatment, regular monitoring is conducted to assess the response to the therapy.

The response is evaluated using imaging techniques and clinical assessments based on the Cheson IWG 2014: Lugano Classification.

4 completion of treatment

The end of treatment is defined after completing the 6 cycles of R-CHOP and 2 cycles of tazemetostat and rituximab.

Permanent treatment discontinuation occurs when all treatments, including rituximab, CHOP, and tazemetostat, are stopped.

Who Can Join the Study?

Patients with a type of cancer called Diffuse Large B Cell Lymphoma (DLBCL) that is untreated or has changed from a slower-growing lymphoma, or patients with a specific type of Follicular Lymphoma.
Patients must have a left ventricular ejection fraction (LVEF) of at least 50%. This is a measure of how well the heart is pumping blood.
Patients need to provide enough tissue from a biopsy for a detailed examination.
Men with partners who can become pregnant must agree to use reliable birth control for 12 months after the last treatment.
Women who can become pregnant must agree to use reliable birth control or avoid heterosexual contact for specific periods before, during, and after the study.
Patients must be covered by a social security system (only applicable in France).
Patients must understand and speak one of the official languages of the country where the study is conducted.
For phase II patients, the disease must be measurable by a CT scan or clinical examination and show activity on a PET scan.
Patients with DLBCL must be between 60 and 80 years old, and those with Follicular Lymphoma must be between 18 and 80 years old.
Patients must have an ECOG performance status of 0, 1, or 2, which indicates their level of functioning and ability to care for themselves.
Patients must sign an informed consent form, agreeing to participate in the study.
Patients must have a life expectancy of at least 90 days (3 months) before starting the study drug.
Patients must have adequate kidney function, measured by a creatinine clearance greater than 40 mL/min.
Patients must have adequate bone marrow function, with specific levels of white blood cells, platelets, and hemoglobin.
Patients must have adequate liver function, with specific levels of bilirubin and liver enzymes. Patients with past Hepatitis B or C can participate if certain conditions are met.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with Diffuse Large B Cell Lymphoma or are not high-risk Follicular Lymphoma patients treated with R-CHOP cannot participate.
Individuals who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.
Both male and female patients are considered, but those who do not meet other criteria will be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Centre Hospitalier De Perpignan	Perpignan	France
Centre Hospitalier D Avignon	Avignon	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Metropole Savoie	Chambery	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Covdbr Lxvk Bqxvtb	Lyon	France
Csisbo Haxhbekziqi Eo Ufqffuporfmoe De Lyhbzqz	Limoges	France
Cawsju Hnsehhxhpqb Urfznuxonjbjz Dm Datek	Dijon	France
Bkxbjygc Udxkslacxp Hxgwlplg Cubblv	Besançon	France
Ieskivkr du Cwcvdgoanmsd Hweeitjfojc Uwqghtrckclma db Smdct Egwfeqi (dxadarh	Saint Priest En Jarez	France
Iceskwct Pvbulhbgvkeafvp Cuftlq Cjhfip	Marseille	France
Hmdsidfj Uosxwhnhgjxcaj Stjuzhtlnf &hjcdym Hyoggza dd Huqjjggzyil	STRASBOURG, Alsace	France
Izojpvwe Cnant	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.09.2020
France	Not recruiting	30.09.2020

Trial locations

Investigated drugs:

Tazemetostat is a medication being studied for its potential to treat certain types of lymphoma, specifically Diffuse Large B Cell Lymphoma (DLBCL) and high-risk Follicular Lymphoma (FL). It is being tested in combination with other treatments to see if it can improve the response rate in patients. Tazemetostat works by targeting specific proteins in cancer cells, which may help to slow down or stop the growth of the cancer.

Rituximab is a medication used in the treatment of certain types of cancer, including lymphomas. It is a type of therapy known as a monoclonal antibody, which works by targeting and attaching to specific proteins on the surface of cancer cells. This can help the immune system to recognize and destroy these cancer cells more effectively.

CHOP is a combination of chemotherapy drugs used to treat lymphoma. It includes four different medications: Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. Each of these drugs works in a different way to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. CHOP is a standard treatment regimen for certain types of lymphoma and is used in combination with other therapies to improve treatment outcomes.

Investigated diseases:

Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease can cause symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. It progresses quickly and requires prompt medical attention to manage its symptoms and effects on the body.

Follicular Lymphoma – This is a slow-growing type of non-Hodgkin lymphoma that affects the lymphatic system, primarily involving B-cells. It often presents with painless swelling of lymph nodes, fatigue, and sometimes fever or night sweats. The disease typically progresses slowly, with periods of stability and occasional flare-ups. Over time, it can transform into a more aggressive form of lymphoma, requiring careful monitoring and management.

Trial ID:

2024-515846-18-00

Protocol code:

Epi-RCHOP

NCT ID:

NCT02889523

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of Tazemetostat with R-CHOP for Newly Diagnosed Diffuse Large B Cell Lymphoma or High-Risk Follicular Lymphoma Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?