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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Kidney Injury (AKI) Acute Kidney Injury B Cell Lymphoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infusion of CD19 CAR T Cell Kidney Diseases Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nephrology department, Centre hospitalier Lyon Sud

Pierre-Bénite, France, 69495

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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…

Treatment and study plan

Incidence of acute kidney injury

Biological

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.

Describe risk factors in AKI occurrence.

Other

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.

Focus on patient with chronic kidney disease at baseline

Other

Looking at the subgroup with chronic kidney disease at baseline : are the outcomes different in this population ? Efficacity of CAR-T ? More adverse effects ?

Long term evolution after treatment by CAR-T cells

Other

Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.

Primary outcomes

Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.

Time frame: AKI from the day of the injection of CAR-T cells, until 28 days after the injection.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: AKI CAR

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 3, 2025
Registry last updated: Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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