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

NCT07101913 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-08-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-12-01
Completion
2026-04-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07101913 on ClinicalTrials.gov