Study 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 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.
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Request More InfoInterventions
FludarabineDRUG
Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4)
CyclophosphamideDRUG
All patients will receive Cyclophosphamide 500 mg/m2 IV on days -6 and -5 (or -7 and -6).
FludarabineDRUG
Targeted fludarabine LD: Fludarabine 40 mg/m2/dose x 2 doses on days -6 and -5 (or
-7 and -6), with doses on days -4 and -3 (or -5 and -4, if starting lymphodepletion on day -7) adjusted based on PK analysis to target a cumulative area under the curve (AUC) of 18 mg\*h/L (range 17.5-18.5mg\*h/L)
CAR-TBIOLOGICAL
will be infused based on institutional guidelines.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | United States |
| Cincinnati Children's Hospital Medical Center (Data Collection Only) | Cincinnati | Ohio | United States |
| Children's Hospital of Philadelphia (Data Collection Only) | Philadelphia | Pennsylvania | United States |