Study on Fludarabine Dosing for Children and Young Adults with B-cell Acute Lymphoblastic Leukemia

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07223021

Provider View

This clinical trial is exploring whether a new way of giving the drug fludarabine can improve treatment for children and young adults with B-cell acute lymphoblastic leukemia (B-ALL) who are receiving CAR T-cell therapy. The study will compare the new dosing method with the standard one to see which is more effective and assess its impact on quality of life.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new dosing method for the drug fludarabine can be a better way to prepare children and young adults with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia (B-ALL) for CAR T-cell therapy. Researchers will compare this new method with the standard dosing to see which works better. They will also check if the new method is practical, what side effects it might have, and how it affects the participants' quality of life by using questionnaires.

Eligibility Criteria

Inclusion Criteria

  • Have B-cell acute lymphoblastic leukemia (B-ALL) and are eligible for CAR T-cell therapy.
  • Weigh more than 9 kg at the time of chemotherapy.
  • Have good organ function, including:
    • Liver: Bilirubin level of 2 mg/dL or less, unless due to a harmless condition.
    • Liver: AST and ALT levels less than 5 times the normal limit for age, unless related to leukemia.
    • Kidneys: A GFR of 70 ml/min/1.73m² or higher.
    • Heart: Heart's pumping ability of 50% or more.
    • Lungs: Oxygen levels of 90% or higher on room air.
  • Have a good performance status:
    • Age 16 and older: ECOG score of 1 or less, or Karnofsky score over 60%.
    • Under 16: Lansky score of 60% or more.
  • Willing to participate and provide written consent from parents or guardians, and assent from the patient if appropriate.

Exclusion Criteria

  • Have allergies or reactions to the study drugs or similar medications, including fludarabine, cyclophosphamide, and tisagenlecleucel.
  • Have tisagenlecleucel that does not meet the required standards.
  • Have a serious and uncontrolled infection confirmed by tests or imaging.
  • Are unable to give informed consent or follow the treatment plan.
  • Are pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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