Occurrence of Acute Kidney Injury After CAR-T Cells Treatments in B-cell Lymphoma.
AKI CAR
Incidence and Risk Factors of Acute Kidney Injury (AKI) After Anti-CD19 CAR-T Cells Treatments in B-cell Lymphoma and Long Term Evolution.
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 3, 2025
July 1, 2025
8 months
July 28, 2025
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
CAR-T cells treatment
All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
Interventions
* 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.
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.
Looking at the subgroup with chronic kidney disease at baseline : are the outcomes different in this population ? Efficacity of CAR-T ? More adverse effects ?
Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.
Eligibility Criteria
All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.
You may qualify if:
- Patients followed in haematology center in "Hospices civils de Lyon"
- For a B-cell lymphoma
- Treated by anti-CD19 CAR-T cells
You may not qualify if:
- Less than 18 years old
- Patients with legal protection measure
- CAR-T cells therapy for another disease : leukemia, autoimmune disease…
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nephrology department, Centre hospitalier Lyon Sud
Pierre-Bénite, France, 69495, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
April 1, 2025
Primary Completion
December 1, 2025
Study Completion
April 1, 2026
Last Updated
August 3, 2025
Record last verified: 2025-07