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RecruitingPhase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
1 Year and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The researchers will measure quality of life by having participants complete questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares fludarabine doses based on how the body handles the drug with standard doses before CAR T-cell therapy, a treatment that uses changed immune cells to fight cancer. It is for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or has not responded to treatment. Researchers will check how well the dosing works, how practical it is, side effects, and quality of life through questionnaires.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have B-ALL and qualify for tisagenlecleucel, an approved CAR T-cell therapy.
  • Weigh more than 9 kilograms (about 20 pounds) when starting chemotherapy to lower immune cells.
  • Have liver blood tests within the study limits, with some exceptions for an inherited condition or leukemia-related changes.
  • Have a kidney filtering test result of at least 70.
  • Have a heart scan within 6 weeks of screening showing that the heart pumps out at least 50% of its blood with each beat.
  • Have a blood oxygen level of at least 90% while breathing room air.
  • Meet the study's age-based scores for ability to do daily activities.
  • The patient, parent, or legal guardian must give written permission before study screening. Children must also agree when appropriate for their age.

Who can't join

  • Have a known allergy or other reaction that makes the study drugs, related drugs, or their ingredients unsafe.
  • Have a tisagenlecleucel product that does not meet required standards.
  • Have a serious active infection that is not controlled.
  • The patient, parent, or guardian cannot give informed permission or follow the treatment plan.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients with B-ALL and eligible to receive commercial tisagenlecleucel. * Patient's weight \> 9 kg at time of lymphodepleting chemotherapy * 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 mg/dL * 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 treatment * Age \< 16 years: Lansky ≥ 60% at treatment * 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. Exclusion Criteria: * 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

Study sites (5)

NY

OH

PA

TX