Randomized Study for Comparison of Reduced Intensity Conditioning Protocols Containing Either Thymoglobuline or Alemtuzumab in Patients Undergoing Allogeneic Transplant From Voluntary Unrelated Donors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 22
- 主要终点
- Safety:
研究概览
简要总结
The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.
详细描述
The reduction of intensity of conditioning is currently indicated for patients who cannot undergo standard myelo-ablation due to their age, comorbidities or type of pathology. Furthermore, the rationale to use RIC regimens is based on the observation that the infusion of alloreactive donor lymphocytes may yield to a graft versus tumour effect. However, in this kind of regimens the morbidity and TRM due to GvHD are still a concern and in vivo T-depletion is a necessary treatment. Both monoclonal (Alemtuzumab) and polyclonal T-depletion protocols carry risks and benefits. Benefits being a better prophylaxis for GvHD, and risks being an higher incidence of post-transplantation infections and relapse. At the moment, it is not clear which type of regimen, monoclonal or polyclonal, is better for the treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual)
- •Group 2: patients <= 65 yo suffering from lympho-proliferative diseases according the REAL classification:
- •High-doses chemotherapy relapsed CLL (B and T)
- •Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy
- •Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy
- •Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy
- •Advanced (stage ≥ III A) or relapsed T lymphomas
- •Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens
- •Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy
- •Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells.
排除标准
- •Performance status < 70% (Karnofsky)
- •Left ventricular cardiac ejection fraction < 40% or receiving treatment for heart failure
- •DLCO pulmonary < 40% or receiving continuous oxygen therapy
- •Neuropathy (previous or at present)
- •Pregnancy
- •Patients with arterial hypertension not controlled with multi-pharmacological treatments
- •HIV positive
- •B-CLL with clear evidence of transformation into Richter syndrome
- •Mycosis fungoides with clear evidence of transformation into blasts
- •Hodgkin's disease refractory to chemotherapy
- •Absence of informed consent
- •Psychiatric disease or other condition compromising the signing of the informed consent form or compliance with the treatment
研究组 & 干预措施
1
Alentuzumab
干预措施: Alentuzumab (Drug)
2
Globulina antilinfocitaria
干预措施: Globulina antilinfocitaria (Drug)
结局指标
主要结局
Safety:
时间窗: 3 years
Overall Survival
时间窗: 3 years
Event Free Survival and Disease Free Survival
时间窗: 3 years
Major infective complications (CMV and EBV related PTLD)
时间窗: 3 years
Acute and chronic GvHD
时间窗: 3 years
次要结局
- Haematological and immunologic reconstitution(3 years)
- Incidence of CMV and EBV reactivation(3 years)
- Other toxicities(3 years)
- Need for DLI(3 years)
- Other infective complications(3 years)