NCT03628053撤回3 期
Tisagenlecleucel Versus Blinatumomab or Inotuzumab for Adult Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia: A Randomized Open Label, Multicenter, Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This trial aims to compare the benefits and risks of tisagenlecleucel to blinatumomab or inotuzumab in adult patients with relapsed or refractory ALL. This trial investigates tisagenlecleucel as an additional treatment option for this patient population with high unmet medical need.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age ≥ 18 years.
- •Subject with CD19-expressing B-ALL.
- •Adequate organ function.
- •Patients considered in any of the following settings are eligible:
- •Untreated first or second relapse
- •Refractory to primary induction therapy
- •Refractory to first salvage therapy or
- •Relapse after allogenic stem cell transplant.
排除标准
- •Patients presenting with untreated first relapse of ALL more than 24 months after initial diagnosis
- •Presence of extra-medullary disease.
- •History or presence of clinically relevant CNS pathology, or uncontrolled CNS leukemia.
- •History of Veno-occlusive Disease (VOD).
- •Active neurological autoimmune or inflammatory disorders.
- •Active acute Graft-versus-Host Disease (GvHD), grade 2-
- •Other protocol-defined Inclusion/Exclusion may apply.
研究组 & 干预措施
Tisagenlecleucel arm
Experimental
Patient to receive tisagenlecleucel after optional bridging therapy and lymphodepleting chemotherapy.
干预措施: Tisagenlecleucel (Biological)
Control arm
Active Comparator
blinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy
干预措施: Blinatumomab (Drug)
Control arm
Active Comparator
blinatumomab or inotuzumab per investigator's discretion after optional bridging chemotherapy
干预措施: Inotuzumab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 4 years
Time from randomization to death for any reason
次要结局
- Event Free Survival (EFS)(4 years)
- Percentage of patients who achieved MRD negative CR/CRi(4 years)
- Overall response rate(4 years)
- Duration of response (DOR)(4 years)
- Probability of patients who achieved CR/CRi at month 12(4 years)
- Prevalence of immunogenecity(4 years)
- Incidence of immunogenecity(4 years)
- Impact of immunogenicity on clinical response(4 years)
- Cellular kinetic profile by qPCR(4 years)
- Cellular kinetics profile by flow cytometry(4 years)
- Relationship between dose and response(4 years)
- Relationship between exposure and response(4 years)
- Relationship between dose and cellular kinetic(4 years)
- EQ-5D-3L(4 years)
- EORTC QLQ-30(4 years)
研究者
相似试验
招募中
2 期
Tislelizumab Plus Cetuximab and Irinotecan vs Third-line Standard-of-care in Refractory mCRCColorectal Neoplasms MalignantNCT05278351Shanghai Zhongshan Hospital87
进行中（未招募）
2 期
Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic LeukemiaPhiladelphia Chromosome-PositiveAcute Lymphoblastic LeukemiaNCT04329325Memorial Sloan Kettering Cancer Center17
招募中
2 期
Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCCRecurrent Hepatocellular CarcinomaNCT04615143Sun Yat-sen University80
已完成
4 期
Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas TransplantationGraft RejectionNCT00331162Wake Forest University Health Sciences222
已完成
2 期
Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPALMixed Phenotype Acute Leukemia (MPAL)Measurable Residual Disease (MRD)NCT04827745University of Maryland, Baltimore2