NCT07101913

Occurrence of Acute Kidney Injury After CAR-T Cells Treatments in B-cell Lymphoma.

Incidence and Risk Factors of Acute Kidney Injury (AKI) After Anti-CD19 CAR-T Cells Treatments in B-cell Lymphoma and Long Term Evolution.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to describe the incidence of AKI after CAR-T cells therapy in B-cell lymphoma. With the aim of highlight risk factors in AKI occurrence. Then, look at outcomes in the subgroup with chronic kidney disease at baseline. Finally, the investigators will examine long term evolution of kidney function.

Conditions

• Acute Kidney Injury (AKI)
• Infusion of CD19 CAR T Cell
• B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Incidence of acute kidney injury	* Creatinine measurement before lymphodepletion chemotherapy, before CAR-T cells injection (day 0) and at day 1, day 3, day 5, day 7, day 10, day 14, day 21 and day 28. * AKI according to 2012 KDIGO.
OTHER	Describe risk factors in AKI occurrence.	Comparison of caracteristics between participants with AKI and participants without AKI : * Baseline caracteristics of participants : age, gender, BMI (Body mass index), medical history… * Caracteristics of hematology disease : severity of lymphoma, previous treatments (chemotherapy, autologous/allogenic stem cell transplant), type of CAR-T cells (axi-cel, tisa-cel) * Other adverse affects : cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) * Use of nephrotoxic medications Informations found in medical field.
OTHER	Focus on patient with chronic kidney disease at baseline	Looking at the subgroup with chronic kidney disease at baseline : are the outcomes different in this population ? Efficacity of CAR-T ? More adverse effects ?
OTHER	Long term evolution after treatment by CAR-T cells	Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

1 site across 1 country: France