Follicle centre lymphoma diffuse small cell lymphoma – Trials in Disease

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Ongoing Clinical Trials for Follicle Centre Lymphoma Diffuse Small Cell Lymphoma

There are currently 2 ongoing clinical trials investigating new treatments for follicle centre lymphoma diffuse small cell lymphoma. These studies are testing innovative therapies including CAR T-cell therapy and targeted medications across several European countries.

Clinical trial locations

Study on Lisocabtagene Maraleucel for Adults with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma

This trial is testing a treatment called lisocabtagene maraleucel, also known as JCAR017, for patients whose lymphoma has returned after treatment or has not responded to previous therapies. This is a form of CAR T-cell therapy, which works by modifying a patient’s own immune cells to better recognize and destroy cancer cells.

Main inclusion criteria: To participate, patients must be at least 18 years old and have either follicular lymphoma or marginal zone lymphoma confirmed by testing within the past 6 months. The disease must be measurable on medical imaging scans and must have either returned after treatment or not responded to previous therapies. Patients need to have received a certain number of prior treatments including specific types of drugs. Good vascular access is required for a procedure called leukapheresis, which collects white blood cells from the bloodstream. Patients must also have adequate organ function and be able to carry out daily activities with little or no assistance. Women who can become pregnant must use effective birth control and have negative pregnancy tests, while all patients must agree not to donate blood, organs, or reproductive cells for at least one year after treatment.

Main exclusion criteria: Patients cannot participate if they have a different type of cancer than the one being studied, have an unresolved recent infection, are pregnant or breastfeeding, or have a history of severe allergic reactions to similar treatments. Those with other serious medical conditions that could interfere with the study, recent major surgery without full recovery, recent treatments that could affect study results, or substance abuse issues are also excluded. Patients who cannot follow study procedures or are participating in another clinical trial at the same time cannot join this study.

Study focus: The trial aims to evaluate how effective and safe JCAR017 is for treating these types of lymphoma. After joining and confirming eligibility, patients undergo leukapheresis to collect their white blood cells. Before receiving the main treatment, patients receive a short course of chemotherapy to reduce existing immune cells and help the new treatment work better. The modified cells are then given back to the patient through an intravenous infusion. Throughout the study, patients are closely monitored with imaging tests and regular health check-ups to assess how the cancer responds to treatment and to watch for any side effects. Long-term follow-up continues to evaluate the treatment’s effectiveness and safety over time.

Investigational drug: JCAR017 is a CAR T-cell therapy that enhances the body’s natural immune defenses against cancer by modifying the patient’s own T cells to target and attack lymphoma cells more effectively.

Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials

This study evaluates the long-term safety of tazemetostat, an oral medication given as film-coated tablets, in patients who have previously participated in other tazemetostat clinical trials and have shown benefit from the treatment. The study monitors patients who continue taking tazemetostat either alone or combined with other approved or experimental medications.

Main inclusion criteria: Patients must currently be receiving tazemetostat treatment with proven clinical benefit, either alone or in combination with other medications as part of a clinical trial. They must be willing to provide written informed consent and follow all study requirements. A life expectancy of more than 3 months is required, along with adequate blood cell counts, bone marrow function, blood clotting factors, kidney function, and liver function. Women who can become pregnant must have a negative pregnancy test at study entry and agree to use both a highly effective birth control method and a barrier method during treatment and for 6 months afterward. Men must either have had a vasectomy and use condoms, or they and their partners must use effective contraception during treatment and for 3 months after stopping.

Main exclusion criteria: Patients cannot participate if they are not currently receiving tazemetostat in a previous clinical study, have experienced severe side effects during previous treatment, are unable to comply with long-term safety monitoring, have developed medical conditions making continued treatment unsafe, or have withdrawn consent from their previous study. Those who have missed scheduled doses, failed to follow study procedures, developed progressive disease while on treatment, are participating in other trials simultaneously, have contraindications to tazemetostat, or cannot continue long-term follow-up visits are also excluded.

Study focus: The trial tracks any side effects that may occur and how well patients tolerate the medication over an extended period. Researchers monitor various health measures including blood cell counts, kidney function, and liver function. The study also tracks how long patients survive while receiving treatment. The medication is provided according to each patient’s previous treatment plan, with the study planned to continue until September 2025.

Investigational drug: Tazemetostat is an EZH2 inhibitor that works by blocking the EZH2 protein, which plays a crucial role in controlling gene expression and cancer cell growth. This represents an innovative approach in targeted cancer therapy for certain types of lymphomas and solid tumors.

Summary

The two ongoing clinical trials for this condition represent different approaches to treatment. One study focuses on an innovative CAR T-cell therapy that modifies patients’ own immune cells to fight cancer, while the other evaluates the long-term safety of a targeted oral medication. Geographically, trials are concentrated primarily in Western European countries, with France hosting both studies, and the CAR T-cell therapy trial having a broader presence across Austria, Germany, Italy, Spain, and Sweden. Poland also hosts the tazemetostat safety study. These trials offer options for patients whose disease has returned or not responded to previous treatments, as well as for those who have already benefited from tazemetostat and wish to continue under careful monitoring.

Ongoing Clinical Trials on Follicle centre lymphoma diffuse small cell lymphoma

  • Study of Long-term Safety of Tazemetostat in Patients Who Previously Participated in Tazemetostat Clinical Trials

    Not recruiting

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    Investigated drugs:
    France Poland