Multicenter, Openlabel, Phase II Intergroups (GELTAMO/GETH) Trial, on the Use of Alemtuzumab for Unrelated Donor Reduced Intensity Conditioning Allogenic Transplant in Hematological Malignancies Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- CABYC
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Analyze the results of incidence and severity of acute and chronic GVHD
研究概览
简要总结
The purpose of this study is to analyze the results of incidence and severity of acute and chronic GVHD, (see addendum II) and of disease free survival with Alemtuzumab use (MabCampath®) in haematopoietic transplant of unrelated donor with reduced intensity conditioning.
详细描述
Each patient will be assigned to one of the two dosing schedules and total dose of drug envisaged in the study. The assignation to conventional or reduced Alemtuzumab (MabCampath) dose will be done depending on the age and risk of suffering GVHD, in function of variables coming from general experience.
High risk of GVHD criteria:
Gender incompatibility: male patient of female donor. HLA incompatibility: non identical high resolution typing in HLA A, B, C, DRB1, DQB1 (identity less than 10/10 alleles by high resolution) Age of patient more or equal than 55 years
Conventional doses in high risk (at least one criterion of GVHD high risk):
100 mg de Alemtuzumab IV total dose in 5, 20 mg fractions, days -8, -7, -6, -5 and -4.
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
- 40 Years 至 65 Years（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
- •Liver (≥ x3 UNL), kidney (GF <40ml/min), cardiac (LVEF <40%) or respiratory (DLCO & FVC <40% of expected) function tests impairment.
- •HIV injection.
- •Absence of signed informed consent.
- •Progressive disease previous to transplant or not fulfilling the above mentioned response criteria.
- •Other co-morbidities that contraindicate CT.
- •Pregnant and/or breast-feeding women or with pregnancy risk by inadequate contraception.
- •Life expectancy <6 months.
- •Mental or psychiatric deficiency impeding adequate understanding and consent to therapy
- •Hypersensitivity as shown by anaphylactic reaction to any of the DRUGS used in the trial.
- •Active infectious process.
研究组 & 干预措施
1
High risk patients (at least one GVHD high risk criterion):
Total dose 100 mg in 5 doses of 20 mg, days -8 to -4 (inclusive).
干预措施: Alemtuzumab (Drug)
2
Low Risk patients (no GVHD high risk criterion):
Total dose 50 mg inn 5 dosing OF 10 mg, days -5 to -1 (inclusive).
干预措施: Alemtuzumab (Drug)
结局指标
主要结局
Analyze the results of incidence and severity of acute and chronic GVHD
时间窗: 3 years
次要结局
未报告次要终点