Ongoing Clinical Trials for Non-Hodgkin’s Lymphoma Unspecified Histology Indolent
There is currently 1 ongoing clinical trial for patients with relapsed or refractory indolent non-Hodgkin’s lymphoma. This trial is investigating a personalised cell therapy approach for patients whose lymphoma has returned or not responded to previous treatments. The trial is being conducted in France and focuses on using the patient’s own modified immune cells to target cancer.
Clinical trial locations
Study of Axicabtagene Ciloleucel for Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma
This clinical trial is testing axicabtagene ciloleucel, a specialised treatment that uses a patient’s own immune cells to fight cancer. The treatment involves collecting white blood cells from the patient, modifying them in a laboratory to recognise and attack cancer cells, and then returning them to the patient through an intravenous infusion.
Who can participate:
- Adults aged 18 years or older
- Patients with follicular lymphoma or marginal zone lymphoma that has worsened after at least two previous treatments combining chemotherapy and immune therapy (such as R-bendamustine or R-CHOP)
- Measurable disease that can be seen on scans
- No history of lymphoma affecting the brain or spinal cord
- Good overall physical health with an ECOG performance status of 0-1, meaning fully active or able to carry out light work
- Adequate kidney, liver, lung, and heart function
- For women of childbearing potential, a negative pregnancy test is required
- Willingness to use birth control for 12 months after receiving the treatment
Who cannot participate:
- Patients with types of lymphoma other than follicular, marginal zone, or indolent non-Hodgkin lymphoma
- Pregnant or breastfeeding women
- Patients with certain medical conditions that could interfere with treatment or outcomes
- Those unable to provide informed consent or understand study requirements
- Recent participants in other clinical trials
- Patients who have received certain treatments or medications that could affect study results
What the trial involves:
The study follows a structured approach beginning with a procedure called leukapheresis to collect white blood cells. Before receiving the main treatment, patients are given preparatory medications including fludarabine and cyclophosphamide through intravenous infusion. The main treatment, axicabtagene ciloleucel, is then administered as a single infusion. Following treatment, patients undergo regular monitoring through blood tests and other evaluations at specific time points including Day 7, Week 2, and Month 3. Long-term follow-up continues for up to 15 years to track outcomes and any side effects.
Treatment goal:
The primary focus of this trial is to evaluate how effective axicabtagene ciloleucel is for patients whose lymphoma has returned or has not responded to previous treatments. The study monitors how the cancer responds to treatment by checking levels of modified immune cells in the blood and observing changes in the disease. Safety is also assessed by tracking any side effects participants may experience.
Investigational treatment:
The main investigational drug is axicabtagene ciloleucel, a type of CAR T-cell therapy. This treatment works by modifying a patient’s own immune cells (T-cells) in a laboratory to help them recognise and attack cancer cells more effectively. Additional medications used to support the treatment process include tocilizumab, dexamethasone, fludarabine, cyclophosphamide, methylprednisolone, diphenhydramine, mesna, and paracetamol. These supporting medications help manage side effects or enhance the effectiveness of the main treatment.
Summary
Currently, there is one active clinical trial for patients with relapsed or refractory indolent non-Hodgkin’s lymphoma. This trial is located in France and focuses on an innovative cell therapy approach using axicabtagene ciloleucel. The treatment represents a personalised medicine approach, as it uses each patient’s own immune cells that are specially modified to target their specific cancer. The trial is designed for patients who have already tried at least two previous treatment combinations without success, offering a potential new option for those with limited alternatives. The long-term follow-up period of up to 15 years demonstrates a commitment to understanding both the immediate and long-term effects of this therapy.
