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)
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.
Child to Adult
Patients age 26 years and younger with R/R B-ALL who have received commercial tisagenlecleucel and have an additional dose available for early reinfusion.
- Patients with R/R B-ALL who have received commercial tisagenlecleucel and have (an) additional dose(s) available for early reinfusion. - History of CD19 expressing (in peripheral blood or bone marrow by flow cytometry) B-ALL prior to tisagenlecleucel infusion. - Peripheral blood B-cell aplasia (BCA) within 14 days prior to reinfusion. - Minimal residual disease negative complete remission (CR/CRi) in bone marrow within 14 days prior to reinfusion, including resolution of extramedullary disease - Patients with tisagenlecleucel that is deemed out of specification (OOS) will be permitted on this protocol if the reason for OOS is deemed to not impact the toxicity and efficacy profile of CAR T cell therapy - Patients age: < 26 years at time of first tisagenlecleucel order placement - Recovered from severe toxicities following initial dose of tisagenlecleucel - Adequate organ function at time of treatment is required - Adequate performance status - Patient must be enrolled on institutional CIBMTR reporting protocol for immune effector cells (IEC)/CAR T cells
Treatment
Childrens Hospital Colorado
Vanessa Fabrizio, MD, MS
Protocol Number: 22-1340
More information available at ClinicalTrials.gov: NCT05460533
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