Kymriah Real-world Effectiveness in ALL (KareALL): a Retrospective Chart Review Study of Tisagenlecleucel-treated ALL Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Remission Rate
研究概览
简要总结
This was a retrospective, cross-sectional, center-based chart review study that collected real-world data for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) patients receiving tisagenlecleucel (tisa-cel). Five centers in the United States were included for the study.
The date of the initial tisa-cel infusion was defined as the index date. A baseline period from ALL diagnosis to the index date was used to capture patient characteristics including demographics, and disease and treatment history. The study period, defined as the period from tisa-cel infusion to the end of follow-up date, i.e. the last contact date on medical charts or death, whichever was earlier, was used to capture the clinical outcomes of tisa-cel among ALL patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Remission Rate
时间窗: Month 1 and Month 3
Remission rate was defined as the best overall response as either complete remission (CR) or complete remission with incomplete blood count recovery (CRi) to tisa-cel. CR: \<5% blasts in bone marrow based on morphologic assessment, no evidence of extramedullary disease, full recovery of peripheral blood counts (platelets \> 100x10\^9/L, absolute neutrophil \> 1.0x10\^9/L, and circulating blasts \<1%), and blood transfusions independency (i.e., no transfusion or transfusion ≤7 days). CRi: \<5% blasts in bone marrow, no evidence of extramedullary disease, but without full recovery of peripheral blood counts with or without blood transfusions independency.
次要结局
- Demgraphics: Weight(Baseline)
- Time From Tisa-cel Infusion to Subsequent AlloSCT(Baseline up to approximately 3 years)
- Time from Tisa-cel Infusion to B-cell Aplasia(Baseline up to approximately 3 years)
- Number of Patients per Demographic Category(Baseline)
- Number of Patients by Disease Characteristics Category(Baseline)
- Number of Patients by Treatment Characteristics Category(Baseline)
- Lymphoblast Proportion in Bone Marrow Before Tisa-cel Infusion(Baseline)
- ALL Disease Duration at Tisa-cel Infusion(Baseline)
- Time From Initial Diagnosis to First Relapse(From initial diagnosis up to first tisa-cel infusion, approximately 13 years)
- Number of Patients by Time From Initial Diagnosis to First Relapse(Baseline)
- Time From Most Recent Relapse to Initial Tisa-cel Infusion(From initial diagnosis up to first tisa-cel infusion, approximately 13 years)
- Number of Lines of Treatment Prior to Tisa-cel Infusion(Baseline)
- Time From Tisa-cel Infusion to Loss of Follow-up or Death due to Any Cause(Baseline up to approximately 3 years)
- Time From Leukapheresis to Tisa-cel Infusion(From initial diagnosis up to first tisa-cel infusion, approximately 13 years)
- Number of Doses for Initial Tisa-cel Infusion(Baseline)
- Weight Adjusted Transduced Cell Dose Infused in Patients Who Weighed 50 kg or Less at Tisa-cel Infusion(Baseline)
- Total Cell Dose Infused in Patients Who Weighed More Than 50 kg at Tisa-cel Infusion(Baseline)
- Number of Patients by Conditions Experienced After Tisa-cel Infusion(Baseline up to approximately 3 years)
- Number of Patients by Bone Marrow Minimal Residual Disease (MRD) Status(Month 1 and Month 3)
- Duration of Remission (DOR)(Months 1, 6, 12, 18, 24, and 30)
- Relapse-free Survival (RFS)(Months 1, 6, 12, 18, 24, and 30)
- Event-free Survival (EFS)(Months 1, 6, 12, 18, 24, and 30)
- Overall Survival (OS)(Months 1, 6, 12, 18, 24, and 30)
- Number of Patients who had AlloSCT After Tisa-cel Infusion(Up to approximately 3 years)
- Number of Patients by Tisa-cel Reinfusion Received After Initial Infusion(Up to approximately 3 years)
- Time From Initial Tisa-cel Infusion to Tisa-cel Reinfusion(Baseline up to approximately 3 years)
- Number of Patients by Type of new Anticancer Therapy (Other Than AlloSCT or Reinfusion) Received After Tisa-cel infusion(Up to approximately 3 years)
- Number of Patients by B-cell Aplasia Status After Tisa-cel Infusion(Up to approximately 3 years)
- Number of Patients by use of Immunoglobulin (Ig) Replacement Therapy Among Those who Experienced B-cell Aplasia(Up to approximately 3 years)
- Average Dose of Ig Replacement Therapy(Up to approximately 3 years)
- Duration of Ig Replacement Therapy(Up to approximately 3 years)
- Rate of Maintenance of B-cell Aplasia(Months 1, 2, 3, 6, 9, 12, 18, 24, 30)
- Number of Patients by Hospitalizations at Initial Tisa-cel Infusion(Baseline)
- Length of Stay in Hospital for Initial Tisa-cel Infusion(Up to approximately 3 years)
- Number of Patients by Hospitalizations After Tisa-cel Infusion(Up to approximately 3 years)
- Number of Hospitalizations After Tisa-cel Infusion(Up to approximately 3 years)
- Length of Stay in Hospital After Tisa-cel Infusion(Up to approximately 3 years)
- Time From Initial Tisa-cel Infusion to the First Hospitalization(Baseline up to approximately 3 years)
- Number of Patients by Primary Reason for the First Hospitalization(Up to approximately 3 years)
- Number of Patients by ICU Admissions After Tisa-cel Infusion(Up to approximately 3 years)
- Number of ICU Admissions After Tisa-cel Infusion(Up to approximately 3 years)
- Length of Stay per ICU Admission After Tisa-cel Infusion(Up to approximately 3 years)
- Number of Patients by Primary Reason for ICU Admission After Tisa-cel Infusion(Up to approximately 3 years)