Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Rate of CMV reactivation
研究概览
简要总结
Letermovir is approved for the primary prevention of Cytomegalovirus (CMV) reactivation and infection in hematopoietic stem cell transplant recipients. Letermovir may be beneficial in other clinical presentation where CMV reactivates and may alter clinical outcomes. Recently Chimeric Antigen Receptor (CAR) T cells have been used for the treatment of refractory acute leukemia and B cell lymphoma. Reactivation of chronic viral infections, in particular those belonging to the Herpesviridae family can therefore be observed following CAR-T cells treatment.According to first reports, Cytomegalovirus seems to be the main virus detected. Uncontrolled CMV reactivation leads to CMV disease requiring the use of antiviral drugs associated with either hematological toxicity (ganciclovir) or renal toxicity (foscarnet) and is usually associated with poor outcomes. In addition, CMV interplays with the immune system and decreases the immunosurveillance of tumor cells and facilitates the growth or reactivation of other opportunistic infections. Therefore, CMV reactivation could also impact the outcome of CART cells treatment by increasing the existing risk of opportunistic infections in CART cells recipients and thus by increasing morbidity, length stay or require intensive care. Imbalance of the immune system usually correlates with reactivation of persistent virus like Torquetenovirus (TTV), redondovirus or pegivirus found more frequently in Hematopoietic stem-cell transplantation (HSCT) patients or patients requiring intensive care. Whether reactivations of those persistent viruses are associated or precede CMV reactivation deserve careful investigation to identify as early as possible patients at high risk and who could benefit from antiviral preventive treatment.
The objective of this trial is to determine the incidence of CMV reactivation within 3 months after infusion of CAR-T cells in CMV seropositive patients with refractory acute leukemia or B-cell lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •CMV seronegative patients
- •Lack of affiliation to a social security scheme (as a beneficiary or assignee)
- •Patients under guardianship / curatorship
- •Patient under AME (state medical aid)
结局指标
主要结局
Rate of CMV reactivation
时间窗: Up to 3 months after inclusion
Rate of CMV reactivation occurring within the first 3 months after CAR-T-cell infusion in paediatric and adult patients treated for refractory B cell acute lymphoblastic leukemia (B-ALL) and diffuse large B-cell lymphoma (DLBCL).
次要结局
- Correlation between CMV reactivation and the occurrence of other bacterial or fungal infections(Up to 3 months)
- Rate of anellovirus infection(Up to 3 months)
- Rate of redondovirus infection(Up to 3 months)
- Detection of mutations in the CMV DNA polymerase gene in patients under acyclovir or valacyclovir prophylaxis(Up to 3 months)
- Cost of illness of CMV disease(Up to 3 months)
- Rate of CMV disease(Up to 3 months)
- Rate of pegivirus infection(Up to 3 months)
- Correlation between CMV reactivation and the expansion of CAR-T cells(Up to 3 months)
- Correlation between CMV reactivation and other early viral persistent reactivations (anellovirus, pegivirus, redondovirus)(Up to 3 months)
- Rate of CMV reactivation in patients with acute leukemia(Up to 3 months)
- Rate of CMV reactivation in patients with lymphoma(Up to 3 months)
- Health related quality of life (HRQL)) of the study population with or without CMV activation(Up to 3 months)