Personalized chemo boosts CAR T-Cell success in young leukemia patients
NCT ID NCT07223021
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times
Summary
This study tests whether giving a personalized dose of the chemotherapy drug fludarabine before CAR T-cell therapy can improve outcomes for children and young adults with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia. About 130 participants will be randomly assigned to receive either standard or personalized fludarabine dosing. The goal is to see if the personalized approach extends the time without cancer returning or worsening.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College Medical Center (Data Collection Only)
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Children's Hospital of Philadelphia (Data Collection Only)
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Cincinnati Children's Hospital Medical Center (Data Collection Only)
RECRUITINGCincinnati, Ohio, 45229, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Prinses Máxima Centrum (Data Collection and Analysis)
RECRUITINGUtrecht, Netherlands
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Texas Children's Hospital (Data Collection)
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Pre-Transplant drug keep leukemia from returning?
- Fighting fat to fight leukemia: could a diet and exercise plan boost chemo?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can donor immune cells be engineered to fight blood cancer?
- Can a Chemo-Antibody combo beat a tough leukemia?
- Personalized chemo dosing may boost leukemia remission in kids