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

Recruiting now · Phase 3

Conditions studied: B-cell Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID: NCT07223021
Run by: Memorial Sloan Kettering Cancer Center
People needed: 130
Starts: 2025-10-20
Expected to finish: 2028-10-01
Last updated by the study team: 2026-06-12

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify 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

Where it is running

Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Cincinnati Children's Hospital Medical Center (Data Collection Only) — Cincinnati, Ohio, United States (enrolling)
Children's Hospital of Philadelphia (Data Collection Only) — Philadelphia, Pennsylvania, United States (enrolling)
Baylor College Medical Center (Data Collection Only) — Houston, Texas, United States
Texas Children's Hospital (Data Collection) — Houston, Texas, United States

Full record on ClinicalTrials.gov

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