PREV-CART - A multicentric phase III randomized clinical trial open-label, comparing immunoglobulin replacement therapy (IgRT) and antibiotic prophylaxis (AP) in patients treated by CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for a B cell acute lymphoblastic leukemia or a B cell lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 17
- 主要终点
- A composite outcome defined by the occurrence of either recurrent infections (defined by at least 2 episodes requiring a curative systemic antibiotic treatment) or a severe infection (defined by the need of hospitalization) between randomization and M12.
研究概览
简要总结
To compare immunoglobulin replacement therapy (IgRT) to prophylactic antibiotic treatment (AP) following center’s guidelines in the prevention of the occurrence of clinically or microbiologically documented infections within 12 months following randomization, in patients 16-80 years old, treated by CAR-T cells therapy for B-ALL or BCL. The main trial endpoint is a composite outcome defined by the occurrence of either recurrent infections (defined by at least 2 episodes requiring a curative systemic antibiotic treatment) or a severe infection (defined by the need of hospitalization) between randomization and M12.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 16-80 years at inclusion
- •B-cell acute lymphoblastic leukemia or a B-cell lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma)
- •With gammaglobulin <4g/L at the time of lymphodepletion
- •Receiving CD19-targeted autologous CAR-T cells
- •Patients with childbearing potential* should have reliable contraception for the all duration of the study and another 12 months after CAR-T infusion.
- •Contraceptive measures for concerned patients (cf part 6)
- •Informed consent signed by patient or legal representatives
排除标准
- •Any medical history of intolerance to intravenous immunoglobulin
- •With renal failure calculated glomerular filtrate rate <30 mL / min;
- •With hepatic failure or hepatitis or bilirubin> 3 times the upper limit of normal, Serum ALT/AST >=5N
- •With existing serious acute infection
- •Contraindication to immunoglobulin or to prophylactic antibiotherapy administered in this clinical trial
- •No health insurance coverage
- •Females who are pregnant or breastfeeding
- •Participation in another interventional study or being in the exclusion period at the end of a previous study
研究组 & 干预措施
AMOXICILLIN , AMOXICILLIN TRIHYDRATE
干预措施: AMOXICILLIN (Drug)
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
干预措施: IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM. (Drug)
SULFAMETHOXAZOLE AND TRIMETHOPRIM
干预措施: SULFAMETHOXAZOLE AND TRIMETHOPRIM (Drug)
LEVOFLOXACIN, LEVOFLOXACIN
干预措施: LEVOFLOXACIN (Drug)
LEVOFLOXACIN, LEVOFLOXACIN
干预措施: LEVOFLOXACIN (Drug)
AMOXICILLIN , AMOXICILLIN TRIHYDRATE
干预措施: AMOXICILLIN TRIHYDRATE (Drug)
AZITHROMYCIN , AZITHROMYCIN
干预措施: AZITHROMYCIN (Drug)
AZITHROMYCIN , AZITHROMYCIN
干预措施: AZITHROMYCIN (Drug)
结局指标
主要结局
A composite outcome defined by the occurrence of either recurrent infections (defined by at least 2 episodes requiring a curative systemic antibiotic treatment) or a severe infection (defined by the need of hospitalization) between randomization and M12.
A composite outcome defined by the occurrence of either recurrent infections (defined by at least 2 episodes requiring a curative systemic antibiotic treatment) or a severe infection (defined by the need of hospitalization) between randomization and M12.
次要结局
- - Quality of life measured on QLQ-C30 and EQ5D5L
- - Cumulative hazard of severe (requiring hospitalization) infections within 12 months
- - Infection-free survival rate at M12
- - Occurrence of COVID19 infection within 12 months
- - Cumulative incidence of readmissions due to infectious episode after hospital discharge following the infusion of CAR-T cells within 12 months
- - Incidence of adverse events due to IgRT and/or PA between randomization and M12
- - Measures of IgA, IgG, IgM, CD19/CD4/CD8 lymphocytes counts at lymphodepletion, M1, M3, M6, M9, M12
- - Cost effectiveness and cost utility: incremental cost effectiveness/utility ratios
研究者
Dr Florence RABIAN
Scientific
Assistance Publique Hopitaux De Paris