Actively Recruiting
Optimizing Fludarabine Dosing in Children and Young Adults with B-cell Acute Lymphoblastic Leukemia Receiving CAR T-cell Therapy
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-12
130
Participants Needed
5
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether a pharmacokinetics PK-targeted dosing of fludarabine is a better lymphodepletion chemotherapy method for children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia B-ALL who will be treated with tisagenlecleucel CAR T-cell therapy. This Phase 3 study compares the PK-targeted dosing approach with the standard fludarabine dosing to determine which is more effective. The study also evaluates the feasibility of the PK-targeted dosing, monitors side effects, and assesses how the treatment affects participants quality of life through questionnaires. Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide prior to CAR T-cell infusion. One group will get the standard fludarabine dose of 30 mgm2 given four times over days -6 to -3 or days -7 to -4. The other group will receive a PK-targeted fludarabine regimen with 40 mgm2 doses on days -6 and -5 or -7 and -6, with additional doses on days -4 and -3 or -5 and -4 adjusted based on PK analysis to target a specific drug exposure level. All participants receive cyclophosphamide 500 mgm2 intravenously on days -6 and -5 or -7 and -6. CAR T-cell therapy is infused according to institutional guidelines. During the study, participants will be monitored for event-free survival at 28 days as the primary outcome, with survival also tracked up to two years. Researchers will collect information through physical exams, laboratory tests, and quality of life questionnaires. Safety and side effects will be closely observed, and participants organ function and performance status will be assessed to ensure eligibility and ongoing health. The trial is expected to continue until October 2028, with ongoing follow-up visits to evaluate outcomes.
CONDITIONS
Brief Title
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Research Team
K
Kevin Curran, MD
J
Jaap Jan Boelens, MD, PhD
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