An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
详细描述
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
- •Eastern Cooperative Oncology Group (ECOG) score 0-
- •Target on leukemia is >20% positive detected with flowcytometry.
- •Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
- •5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
- •6.No other immunotherapy was received within 3 months.
排除标准
- •Patients are pregnant or lactating.
- •Patients with congenital immunodeficiency.
- •Patients with central nervous system leukemia.
- •Patients with uncontrolled active infection.
- •Patients with active hepatitis B or hepatitis C infection.
- •Patients with HIV infection.
- •Patients with atrial or venous thrombosis or embolism.
- •Patients with myo-infarction or severe arrythmia in the recent 6 months.
- •Other comorbidities that investigators considered not suitable for this study.
结局指标
主要结局
Overall response rate (ORR)
时间窗: 2 years
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
次要结局
- Cumulative incidence of relapse(CIR)(2 years)
- Overall survival (OS)(2 years)
- Leukemia-free survival (LFS)(2 years)
- the duration of CAR-T cells in patients(2 years)
- Number of adverse events(2 years)
研究者
Xiaowen Tang
Chief Physician
The First Affiliated Hospital of Soochow University