Fludarabine dosing for children and young adults with B-cell acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study compares PK-targeted fludarabine dosing to standard fludarabine dosing as lymphodepletion prior to commercial tisagenlecleucel CAR T-cell therapy in children and young adults with relapsed/refractory B‑cell ALL. Participants who meet weight, organ function, and performance status requirements will receive lymphodepleting chemotherapy followed by CAR T infusion and will be followed for safety and efficacy outcomes. The study will measure feasibility of the PK-targeted approach, treatment side effects, and patient-reported quality of life using questionnaires. Enrollment and treatment are coordinated at Memorial Sloan Kettering Cancer Center with additional sites listed for data collection.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Recruiting
• University Children's Hospital Münster (Data Analysis)
  Münster, Germany Recruiting

Study contacts

• Principal investigator: Kevin Curran, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Kevin Curran, MD
• Email: currank@mskcc.org
• Phone: 1-833-MSK-KIDS

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL

  This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.

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• CD22/CD19 CAR-T consolidation for adults with standard-risk B-ALL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.