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drugset / Trial / NCT05950802

Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta

NCT05950802 ↗

Phase 1 Recruiting 40 enrolled University Health Network, Toronto
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.

Timeline

Start
2023-07-14
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 500 mg/m2 —
Subject Cyclophosphamide Other / unclassified 750 mg/m2 —

Indications

diffuse large B-cell lymphoma