Fludarabine exposure in patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity
研究概览
简要总结
The primary objective is to study the pharmacokinetics of F-Ara-A in patients undergoing lymphodepletion therapy prior to CAR-T therapy.
研究设计
- 分配方式
- Na
- 主要目的
- Open label, single arm, single centre, non-randomised, prospective phase IV, pharmacological trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Be able to understand and sign an informed consent
- •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
- •Patients undergoing CAR T-cell therapy for hematological malignancies
- •Planned lymphodepletion chemotherapy regimen containing Fludarabine prior to CAR-T cell therapy.
排除标准
- •Pregnancy or lactation
- •Known allergic reactions to components of the lymphodepletion regimen
- •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
- •Patients on dialysis
- •Renal insufficiency with creatinine clearance < 30 ml/min
- •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
- •Patients with known hemolysis due to Fludarabine use or patients with active decompensated hemolytic anemia.
研究组 & 干预措施
Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion, FLUDARABINE TEVA 25 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INJEKTIONS- ODER INFUSIONSLOESUNG, Fludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie
干预措施: FLUDARABINE TEVA 25 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INJEKTIONS- ODER INFUSIONSLOESUNG (Drug)
Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion, FLUDARABINE TEVA 25 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INJEKTIONS- ODER INFUSIONSLOESUNG, Fludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie
干预措施: Fludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie (Drug)
YESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion
干预措施: YESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion (Drug)
Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion, FLUDARABINE TEVA 25 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INJEKTIONS- ODER INFUSIONSLOESUNG, Fludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie
干预措施: Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion (Drug)
Endoxan 500 mg, poeder voor oplossing voor injectie, Endoxan 1000 mg, poeder voor oplossing voor injectie
干预措施: Endoxan 500 mg, poeder voor oplossing voor injectie (Drug)
CARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusion
干预措施: CARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusion (Drug)
Tecartus 0.4 - 2 x 10e8 cells dispersion for infusion
干预措施: Tecartus 0.4 - 2 x 10e8 cells dispersion for infusion (Drug)
Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion
干预措施: Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion (Drug)
Endoxan 500 mg, poeder voor oplossing voor injectie, Endoxan 1000 mg, poeder voor oplossing voor injectie
干预措施: Endoxan 1000 mg, poeder voor oplossing voor injectie (Drug)
结局指标
主要结局
Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity
Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity
Coefficient of variation (CV) for plasma concentrations of F-Ara-A
Coefficient of variation (CV) for plasma concentrations of F-Ara-A
Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax)
次要结局
- Patient covariates: - Sex - Creatinine - Creatinine clearance - Cystatine C - Cystatine C clearance - Actual body weight (ABW) - Ideal body weight (IBW) - Body mass index (BMI) - Body surface aera (BSA); To be assessed after the last included patient has finished LDC.
研究者
Anke Delie
Scientific
Universitair Ziekenhuis Gent