The DESCAR-T registry was set up at the request of the health authorities to improve our knowledge of CAR T-cell therapies marketed in France to treat patients diagnosed with hematological malignancies. The objective of this registry is to collect data on the efficacy as well as on short- and long-term tolerance of these therapies in real-life setting.
Using the registry data, research projects to answer specific questions can be undertaken. One of these projects aims to better understand the profile of patients in intent-to-treat with CAR T-cells and the efficacy and safety of these therapies in patients diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) after at least two previous lines of cancer therapy.
Why is this study being implemented?
Diffuse Large B-Cell Lymphoma is the most common type of non-Hodgkin lymphoma. Current treatments can cure the majority of patients. However, these treatments are not sufficiently effective for some patients. Either the disease progress despite the treatment (it is then considered “refractory”), or it relapses after a period of remission.
CAR T-cells are innovative therapies that have been offered for more than five years to some patients with relapsed or refractory DLBCL after at least two lines of treatment. Depending on the patient’s profile (e.g. their age) and disease (e.g. how quickly it progresses), other treatments may also be offered to patients. Recently, clinical trials have for instance been exploring the efficacy of bispecific antibodies for these patients. Among others, the pharmaceutical company ABBVIE is currently conducting trials to evaluate the efficacy of a possible new bispecific antibody therapy.
The DESCAR-T registry collects data from the medical records of patients who are offered CAR-T in France, whether they ultimately receive it or not. These data help understand the profile of these patients and the characteristics of their lymphoma. The registry also allows evaluating the real-life efficacy and safety of CAR T-cell therapies and provides important information on the best use to make of these treatments among current and future therapeutic options, such as the one developed by ABBVIE.
What are the objectives of the study?
Firstly, the study aims to describe the real-life profile of patients with DLBCL who are offered CAR-T after two previous lines of treatment. Secondly, it will describe the efficacy and safety of these therapies in patients who ultimately receive CAR T-cells.
This study will provide the company with important information on the place of their therapy compared to current DLBCL therapeutic strategies.
How will the study be carried out?
The study will be carried out using data from the DESCAR-T registry. These analyses will be done by members of LYSARC.
A study report will be sent to ABBVIE, who will only receive a report of aggregated results (no individual data) on a pool of CAR-T therapies. No link can be made between the information in the report and the patients whose data is collected in DESCAR-T.
FOR PATIENTS WHO HAVE BEEN OFFERED CAR-T THERAPY IN FRANCE
What does this project mean for you?
This project concerns patients included in the DESCAR-T registry, diagnosed with Diffuse Large B-Cell Lymphoma, for whom CAR T-cell therapy has been considered (outside clinical trials) in France after two other lines of treatment for this disease.
If you are in this situation and agree for your data to be used for this project, this has no direct implications for you.
What should you do about this study?
– If you would like more information about the processing of your data in the context of DESCAR-T and this project,
Or
– If you wish to exercise your rights regarding your data (access and rectification, limitation of their use),
⇒ inform the doctor at your hospital or centre of care for CAR T-cell therapy, who will contact LYSARC while maintaining your anonymity. You can also notify your decision by email at: dpo@lysarc.org.
– Otherwise, you don’t have to do anything.
You can find more information about your rights in relation to your data “I am participating or have participated in a trial“.