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

Active, not recruiting

• Conditions: Acute Kidney Injury (AKI); Infusion of CD19 CAR T Cell; B Cell Lymphoma
• Interventions: Biological: Incidence of acute kidney injury; Other: Describe risk factors in AKI occurrence.; Other: Focus on patient with chronic kidney disease at baseline; Other: Long term evolution after treatment by CAR-T cells

• Registration Number: NCT07101913
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Primary Completion: 2025-12-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients followed in haematology center in "Hospices civils de Lyon"
• For a B-cell lymphoma
• Treated by anti-CD19 CAR-T cells

Exclusion Criteria

• Less than 18 years old
• Patients with legal protection measure
• CAR-T cells therapy for another disease : leukemia, autoimmune disease...

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAR-T cells treatment	Incidence of acute kidney injury	All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
CAR-T cells treatment	Describe risk factors in AKI occurrence.	All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
CAR-T cells treatment	Focus on patient with chronic kidney disease at baseline	All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
CAR-T cells treatment	Long term evolution after treatment by CAR-T cells	All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.

Primary Outcome Measures

Name	Time	Method
Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.	AKI from the day of the injection of CAR-T cells, until 28 days after the injection.

Trial Locations

Locations (1)

Nephrology department, Centre hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France