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)
Primary Objective
To decrease the loss of peripheral blood B-cell aplasia (BCA) rate at 6-months post-infusion below 10% (from 26% to 9%) through early reinfusion of tisagenlecleucel in pediatric relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) patients.
Description
The primary objective of this phase 2 trial is to decrease the loss of peripheral blood B-cell aplasia (BCA) rate at 6-months post-infusion below 10% (from 26% to 9%) through early reinfusion of tisagenlecleucel in pediatric relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) patients.
Details
Locations
Childrens Hospital Colorado
Principal Investigator
Vanessa Fabrizio
Study ID
Protocol Number: 22-1340
More information available at ClinicalTrials.gov: NCT05460533
Categories
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