Trial intelligence / Profile preview

Fludarabine exposure during lymphodepletion before CAR-T cell therapy

2025-524278-40-00Phase 4Authorised

Sponsor
Ghent University Hospital
Start
Mar 2026
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, DNA Intercalators/Alkylators → Nucleic Acid-Directed Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
Countries
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Overview

Phase 4, open-label, single-arm trial of fludarabine in hematopoietic malignancies, sponsored by Ghent University Hospital. Primary endpoints: 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 and 1 more. Planned start Mar 2026; status: authorised.

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Drugs

fludarabine
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Conditions

hematopoietic malignancies

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