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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Fludarabine 30 mg/m2/dose x 4 doses on days -6 to -3 (or -7 to -4)
All patients will receive Cyclophosphamide 500 mg/m2 IV on days -6 and -5 (or -7 and -6).
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)
will be infused based on institutional guidelines.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGCincinnati Children's Hospital Medical Center (Data Collection Only)
Cincinnati, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia (Data Collection Only)
Philadelphia, Pennsylvania, United States
RECRUITINGBaylor College Medical Center (Data Collection Only)
Houston, Texas, United States
NOT_YET_RECRUITINGTexas Children's Hospital (Data Collection)
Houston, Texas, United States
NOT_YET_RECRUITINGPrinses Máxima Centrum (Data Collection and Analysis)
Utrecht, Netherlands
RECRUITINGcompare the event free survival (EFS )
EFS is defined as time from randomization until non-response at day 28 after CAR T cell infusion, loss of B-cell aplasia \<6 months from the time of CAR T cell infusion, disease relapse, initiation of anti-leukemic therapy or death of any cause
Time frame: 28 days
survival
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.