A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Diagnoza białaczki B-komórkowej i kwalifikacja do terapii tisagenlecleucel
- •Waga ponad 9 kg w momencie rozpoczęcia chemioterapii
- •Prawidłowa funkcja wątroby (niski poziom bilirubiny i enzymów wątrobowych)
- •Prawidłowa funkcja nerek (wartość GFR co najmniej 70)
- •Prawidłowa funkcja serca (wyrzutność lewej komory co najmniej 50%)
- •Prawidłowy poziom tlenu we krwi (co najmniej 90%)
- •Zdolność do samodzielnej opieki lub opieki opiekuna (zależy od wieku)
- •Pisemna zgoda pacjenta lub rodziców na udział w badaniu
✗ Disqualifies
- •Alergia lub nadwrażliwość na fludarabinę, cyklofosfamid lub tisagenlecleucel
- •Otrzymanie preparatu tisagenlecleucel niespełniającego wymogi jakości
- •Aktywna, niekontrolowana infekcja (potwierdzona badaniami)
- •Niemożność zgody lub współpracy z protokołem leczenia
- •Ciąża lub karmienie piersią
Simplified criteria — AI translation
Trial details
- Minimum age
- 1 Year
- Last updated (source)
- August 17, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
Memorial Sloan Kettering Cancer Center
New York, United States
Cincinnati Children's Hospital Medical Center (Data Collection Only)
Cincinnati, United States
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, United States
Baylor College Medical Center (Data Collection Only)
Houston, United States
Texas Children's Hospital (Data Collection)
Houston, United States
Trial contact
Kevin Curran, MD
Jaap Jan Boelens, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/18/2026.
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