Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Determination of MTD by evaluation of hematological and non hematoligical toxicity
研究概览
简要总结
The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •B-ALL (OMS) with >=20% of blasts in bone marrow
- •CD22+ expression >=70% of the blast population
- •All previously treated ALL patients who have experienced relapse or treatment failure
- •At least 15 days since previous treatment
- •Performance status 0 - 2
- •Creatinine clearance >= 50 ml/min (Cockroft formula).
- •Serum bilirubin <= 30 mmol/l
- •Written informed consent
排除标准
- •Meningeal involvement
- •CD22 expression on tumor cells or < 70%
- •HIV positive
- •Active Hepatitis B or C
- •Active infection within 7 days of starting treatment
- •Left ventricular ejection fraction < 50%.
- •Contra-indication to 90Y-DOTA-hLL2
- •Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Participation at the same time in another study in which investigational drugs are used
- •Absence of written informed consent
研究组 & 干预措施
Epratuzumab and 90Y-Epratuzumab
Escalating dose schedule with 5 cohort. For each cohort 3 patients will receive Radio-immunotherapy (RIT ) at Day 1 and Day 8 ± 2 First cohort : 92,5 MBq/m² of 90Y-DOTA-hLL2 associated with hLL2 Second cohort : 185 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Third cohort : 277,5 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Fourth cohort : 370 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2 Fifth cohort : 462.5 MBq/m² d'90Y-DOTA-hLL2 associated with hLL2
干预措施: Epratuzumab and 90Y-Epratuzumab (Drug)
结局指标
主要结局
Determination of MTD by evaluation of hematological and non hematoligical toxicity
The primary endpoint is to evaluate the incidence of dose limiting toxicities (DLT) in order to determine the maximal tolerated dose (MTD) in a dose escalating study design
次要结局
- rate of haematological response