Impact of Lymphodepletion Regimen on the Response to CAR T-cells in Patients With With Relapsed/Refractory Large B-cell Lymphoma

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific treatment called CAR T-cell therapy works for patients with aggressive large B-cell lymphoma that has not responded to previous treatments. The researchers want to understand how two medications, Fludarabine and Cyclophosphamide, used before the CAR T-cell therapy (a process known as lymphodepletion), can affect how well the CAR T-cells grow and fight the cancer, as well as how long patients survive after treatment.

To participate in this study, individuals must be adults aged 18 or older who have received CAR T-cell therapy and are dealing with aggressive large B-cell lymphoma that has not improved after at least one prior treatment. They should also have good kidney function. The trial is not yet recruiting participants, but those who join can expect to help researchers learn more about how these medications influence CAR T-cell therapy outcomes, which could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patient aged 18 years and older
• • Treated with commercial CAR T-cells (Lisocabtagene maraleucel, Tisagenlecleucel, or Axicabtagene ciloleucel), with standard lymphodepletion consisting of Fludarabine and Cyclophosphamide
• • Presenting with aggressive large B-cell lymphoma that is refractory or has relapsed after at least one line of treatment
• • Creatinine clearance \> 50 ml/min (Cockcroft CKD-EPI)
• Exclusion Criteria:
• • Weight ≤ 50 kg
• • Out-of-specification reinfusion product
• • Individual participating in another study with an ongoing exclusion period at the time of inclusion
• • Person under guardianship or curatorship, or deprived of liberty by judicial or administrative decision
• • Patient's opposition to the study