A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Prior to initial tisagenlecleucel cell infusion, lymphodepleting chemotherapy (LDC) is required with standard dosing cyclophosphamide and fludarabine as per standard-of-care (fludarabine 30mg/m^2 /dose x 4 doses and cyclophosphamide 500mg/m^2 /dose x 2 doses). Dose adjustments based off ideal body weight (IBW) and/or per institutional guidelines are allowed. LDC should be completed 2 to 14 days prior to the first tisagenlecleucel infusion. LDC may be repeated in cases where tisagenlecleucel has been delayed by more than 4 weeks. No additional LDC will be given prior to the early reinfusion. ;

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT05460533
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kevin Curran, MD
• Phone: 1-833-675-5437
• Email: currank@mskcc.org
• Status: Recruiting
• Phase: Phase 2
• Start date: July 12, 2022
• Completion date: July 2026