FLUDARABINE PHOSPHATE for Hematological malignancy

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Be able to understand and sign an informed consent\n- Women of childbearing potential (WOCBP) must use a reliable contraception method such as licensed hormonal or barrier methods during chemotherapy/conditioning and up 6 months after chemotherapy for female patients; For male patients use of barrier method should be used during chemotherapy/conditioning and up 6 months after chemotherapy\n- Patients undergoing CAR T-cell therapy for hematological malignancies\n- Planned lymphodepletion chemotherapy regimen containing Fludarabine prior to CAR-T cell therapy."}

Exclusion criteria

• {"criterion_text":"- Pregnancy or lactation\n- Known allergic reactions to components of the lymphodepletion regimen\n- No other line available for blood sampling than the infusion line through which Fludarabine was administered (patients with a double or triple lumen central catheter will not be excluded as a second lumen is available for sampling) and patient unable or unwilling to undergo peripheral blood sampling\n- Patients on dialysis\n- Renal insufficiency with creatinine clearance < 30 ml/min\n- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with program participation, program drug administration, or would impair the ability of the patient to receive program therapy\n- Patients with known hemolysis due to Fludarabine use or patients with active decompensated hemolytic anemia."}

Primary endpoints

• {"endpoint_text":"- Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity","definition_or_measurement_approach":"Calculated from plasma concentration-time data of F-Ara-A (pharmacokinetic analysis)."}
• {"endpoint_text":"- Coefficient of variation (CV) for plasma concentrations of F-Ara-A","definition_or_measurement_approach":"Statistical measure of variability in plasma concentrations of F-Ara-A derived from measured plasma concentration data."}
• {"endpoint_text":"- Maximum observed concentration (Cmax)","definition_or_measurement_approach":"Maximum observed plasma concentration of F-Ara-A from sampled concentration-time data."}

Secondary endpoints

• {"endpoint_text":"- Patient covariates: -\tSex -\tCreatinine -\tCreatinine clearance -\tCystatine C -\tCystatine C clearance -\tActual body weight (ABW) -\tIdeal body weight (IBW) -\tBody mass index (BMI) -\tBody surface aera (BSA); To be assessed after the last included patient has finished LDC.","definition_or_measurement_approach":"Assessment of the influence of listed patient covariates on F-Ara-A exposure; to be evaluated after last included patient completed lymphodepletion chemotherapy (LDC)."}

Belgium

Earliest CTIS Part Ii Submission Date

04-03-2026

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

19

Number Of Sites

1

Number Of Participants

75

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium