A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Start Date
10/20/2025
Completion Date
10/1/2028
Summary
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.
Eligibility Criteria
Age Range: 1 years to No maximum
Interventions
Fludarabine
Cyclophosphamide
Fludarabine
CAR-T
Conditions
Locations
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Cincinnati Children's Hospital Medical Center (Data Collection Only)
Cincinnati, Ohio 45229
United States
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania 19104
United States
Baylor College Medical Center (Data Collection Only)
Houston, Texas 77030
United States
Texas Children's Hospital (Data Collection)
Houston, Texas 77030
United States