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ACTIVE NOT RECRUITING
NCT07101913

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

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-04-01

Completion Date

2026-04-01

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

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.

Locations (1)

Nephrology department, Centre hospitalier Lyon Sud

Pierre-Bénite, France, France