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The INFLUENCE Trial: Improve CAR T cell therapy by optimizing fludarabine exposure
EU CTIS ID: 2025-523096-34-00
What this study is testing
To compare the EFS in patients receiving standard versus targeted fludarabine LD prior to CAR T cell infusion in pediatric/young adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with B-ALL and eligible to receive commercial tisagenlecleucel.
- Patient’s weight >9kg at time 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/1.73m2. (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
- Adequate performance status: Age ≥16 years: ECOG ≤1 or Karnofsky >60% at screening, Age <16 years: Lansky >60% at screening
- Willing to participate as research subject and provide written informed consent from parents/legal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are conducted, according to local, regional or national law and legislation.
You likely can't join if
- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel.
- Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol
- Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA etc.)
- Patient/parent/guardian unable to give informed consent or unable to comply with the treatment protocol.
- Pregnant or lactating women
- Other uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.