Status:
RECRUITING
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Princess Maxima Center for Pediatric Oncology
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
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 lymphoblast...
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 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 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
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT07223021
Start Date
October 20 2025
End Date
October 1 2028
Last Update
January 8 2026
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065