NCT05460533

Phase II Open Label Multicenter Study of Early REinFusion of Tisagenlecleucel to Promote DUrable B-CEll ApLasia in Pediatric and Young Adult Patients With Relapsed/Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia (REFUEL)

Study Summary

The researchers are doing this study to see if early reinfusion of tisagenlecleucel can keep participants in B-CEll ApLasia at 6 months after their first infusion. The researchers will also look at the safety of early reinfusion and how effective it is at treating B-ALL.

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Interventions

TisagenlecleucelBIOLOGICAL
Tisagenlecleucel will be infused based on institutional guidelines. Reinfusion of tisagenlecleucel will occur 30-60 days following the first dose.

Study Locations

FacilityCityStateCountry
Children's Hospital of Los Angeles (Data Collection Only)Los AngelesCaliforniaUnited States
Stanford University (Data Collection Only)StanfordCaliforniaUnited States
Children's Hospital Colorado (Data Collection Only)AuroraColoradoUnited States
Johns Hopkins University (Data Collection Only)BaltimoreMarylandUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Cincinnati Children's Hospital Medical Center (Data Collection Only)CincinnatiOhioUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026