OncoMatch/Clinical Trials/NCT07223021
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Is NCT07223021 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including CAR-T and Fludarabine for b-cell acute lymphoblastic leukemia.
Treatment: Fludarabine · Cyclophosphamide · Fludarabine · CAR-T — The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Lab requirements
Kidney function
Calculated GFR ≥ 70 ml/min/1.73m^2 (Schwartz formula)
Liver function
Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia; AST and ALT < 5x ULN for age, unless thought to be leukemic disease-related
Cardiac function
LVEF ≥ 50% by MUGA, echocardiogram, or cardiac MRI within 6 weeks of screening
Adequate organ function at time of LD is required and is defined: * Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia * Hepatic: AST and ALT < 5x the upper limit of normal for age, unless thought to be leukemic disease-related * Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml/min/1.73m^2. (based on Schwartz formula GFR (mL/min/1.73 m²) = (36.2 × Height in cm) / Creatinine in μmol/L * Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening * Pulmonary: Oxygen saturation as recorded by pulse oximetry of ≥ 90% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
- Cincinnati Children's Hospital Medical Center (Data Collection Only) · Cincinnati, Ohio
- Children's Hospital of Philadelphia (Data Collection Only) · Philadelphia, Pennsylvania
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