RecruitingPhase 3NCT07223021

A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia

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)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

130 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

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

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is looking at the best dose of a chemotherapy drug called fludarabine when used to prepare children and young adults with B-cell acute lymphoblastic leukemia (B-ALL, a type of blood cancer) for a CAR T cell treatment called tisagenlecleucel. The goal is to find out if adjusting the fludarabine dose based on how the body processes the drug leads to better outcomes. **You may be eligible if...** - You have been diagnosed with B-ALL and are eligible to receive the approved CAR T cell treatment called tisagenlecleucel (Kymriah) - You weigh more than 9 kg - Your liver, kidneys, and heart are working adequately - You are able to perform some daily activities (ECOG score 0–1 if 16 or older, or Lansky score 60 or above if younger than 16) - Your parents or guardians (and you, if old enough) are willing to provide informed consent **You may NOT be eligible if...** - You have a known serious allergy to fludarabine, cyclophosphamide, or tisagenlecleucel - Your CAR T cell product is considered out of specification after manufacturing - You have an active, uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4)

DRUGCyclophosphamide

All patients will receive Cyclophosphamide 500 mg/m2 IV on days -6 and -5 (or -7 and -6).

DRUGFludarabine

Targeted fludarabine LD: Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or -7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg\*h/L (range 17.5-18.5mg\*h/L)

BIOLOGICALCAR-T

will be infused based on institutional guidelines.