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Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)
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.
Age
1 - No limit years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center (Data Collection Only)
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, United States
Start Date
October 20, 2025
Primary Completion Date
October 1, 2028
Completion Date
October 1, 2028
Last Updated
February 17, 2026
130
ESTIMATED participants
Fludarabine
DRUG
Cyclophosphamide
DRUG
Fludarabine
DRUG
CAR-T
BIOLOGICAL
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT07429461
NCT06785818
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06863259