Actively Recruiting
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-30
130
Participants Needed
3
Research Sites
153 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
P
Princess Maxima Center for Pediatric Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with B-cell acute lymphoblastic leukemia and eligible for commercial tisagenlecleucel treatment
- Patient weighs more than 9 kilograms at the time of lymphodepleting chemotherapy
- Adequate liver function: serum bilirubin 2 mg/dL or less unless benign congenital hyperbilirubinemia
- Liver enzymes (AST and ALT) less than 5 times the upper limit of normal for age unless related to leukemia
- Adequate kidney function: glomerular filtration rate of 70 ml/min/1.73m2 or higher by Schwartz formula
- Adequate heart function: left ventricular ejection fraction 50% or higher by specific scans within 6 weeks before screening
- Adequate lung function: oxygen saturation of 90% or higher on room air
- Adequate performance status: ECOG 1 or less or Karnofsky above 60% if age 16 or older
- Adequate performance status: Lansky 60% or higher if under age 16
- Willingness to participate with signed informed consent and age-appropriate assent
You will not qualify if you...
- Known immediate or delayed allergic reaction or intolerance to fludarabine, cyclophosphamide, tisagenlecleucel, or related drugs
- Receiving tisagenlecleucel product that is out of specification
- Active and uncontrolled infections confirmed by clinical signs, imaging, or lab tests
- Unable to provide informed consent or comply with the treatment plan
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center (Data Collection Only)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Children's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Kevin Curran, MD
CONTACT
J
Jaap Jan Boelens, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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