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Fludarabine Dosing for B-cell Acute Lymphoblastic Leukemia in Children and Young Adults

This study is looking at two different ways to give a chemotherapy drug called fludarabine to children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) that has come back or is hard to treat. These patients will also receive CAR T-cell therapy (a type of immunotherapy where a patient's own immune cells are modified to fight cancer). Researchers want to see if adjusting fludarabine doses based on how your body processes it (PK-targeted fludarabine) is more effective than the standard fludarabine dose. They will compare how long patients stay free of events (like the cancer returning) at 28 days. The study will also look at how practical the PK-targeted dosing is, any side effects, and how it affects your quality of life. You may be able to join if you have B-ALL, are eligible for commercial tisagenlecleucel (the CAR T-cell therapy), weigh more than 9 kg, and have good organ function. The study plans to enroll 130 participants.

Study design
This is an interventional study comparing two different fludarabine dosing approaches. It plans to enroll 130 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures event-free survival at 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223021

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

Recruiting
PHASE3Ages 1+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~65 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:FludarabineCyclophosphamideCAR-T

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
compare the event free survival (EFS )
Measured over 28 days

Conditions

B-cell Acute Lymphoblastic Leukemia

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Where it's being run

5 sites across 4 states
Texas2
New York1
Ohio1
Pennsylvania1

Study leadership

  • Kevin Curran, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Kevin Curran, MD
[email protected]
1-833-MSK-KIDS
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • compare the event free survival (EFS )28 days

    EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia \<6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause