Occurrence of Acute Kidney Injury After CAR-T Cells Treatments in B-cell Lymphoma.
NCT ID: NCT07101913
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2025-04-01
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
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.
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 ?
Long term evolution after treatment by CAR-T cells
Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.
Interventions
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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.
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.
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 ?
Long term evolution after treatment by CAR-T cells
Creatinine measurement 1 year after CAR-T treatment. Informations found in medical field.
Eligibility Criteria
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Inclusion Criteria
* For a B-cell lymphoma
* Treated by anti-CD19 CAR-T cells
Exclusion Criteria
* Patients with legal protection measure
* CAR-T cells therapy for another disease : leukemia, autoimmune disease…
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Nephrology department, Centre hospitalier Lyon Sud
Pierre-Bénite, France, France
Countries
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Other Identifiers
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24-5297
Identifier Type: -
Identifier Source: org_study_id
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