Patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy, for hematological malignancy
Investigational medicinal product(s)
FLUDARABINE TEVA 25 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INJEKTIONS- ODER INFUSIONSLOESUNGCARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusionFludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusionYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusionTecartus 0.4 - 2 x 10e8 cells dispersion for infusionKymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusionFludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusieEndoxan 1000 mgpoeder voor oplossing voor injectieEndoxan 500 mgpoeder voor oplossing voor injectie
Eligibility
Age group
18-64 years, 65+ years
Sex
Female, Male
Primary endpoint
Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity, Coefficient of variation (CV) for plasma concentrations of F-Ara-A, Maximum observed concentration (Cmax)
Endpoint detail
Patient covariates: - Sex - Creatinine - Creatinine clearance - Cystatine C - Cystatine C clearance - Actual body weight (ABW) - Ideal body weight (IBW) - Body mass index (BMI) - Body surface aera (BSA); To be assessed after the last included patient has finished LDC.
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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