NCT00644371已完成2 期
Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea14 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- progression-free survival
研究概览
简要总结
To evaluate the use of ibritumomab tiuxetan (Zevalin) as part of the non myeloablative conditioning with melphalan, fludarabine and thiotepa in patients submitted to allogeneic transplantation of haematopoietic stem cells from family donor's peripheral blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Histologically confirmed B-cell lymphoma of the following subtypes:
- •Grade 3b follicular lymphoma
- •Mantle-cell lymphoma
- •Transformed B-cell lymphoma
- •Burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
- •High-risk B-cell CD20+ lymphoma defined by
- •Having attained less than PR after two chemotherapy lines
- •Post-transplantation relapse
- •Presence of disease detected through a metabolic approach (PET/CT or else CT+PET) either before or after autologous transplantation
- •Inability to collect enough stem cells for autologous transplantation
- •Stable disease at the time of transplantation
- •Age between 18 and 65
- •Performance status (ECOG) ≤ 2
- •Normal and suitable pulmonary function (DLCO ≥ 30%)
- •Left ventricular ejection fraction (LVEF) determined by ventriculography or echocardiogram ≥ 40%
- •Normal hepatic and renal function, with creatinine ≤ 2 mg/dl and Bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x UNL ; AST, ALT ≤ 2.5 x UNL (≤ 5 x UNL if hepatic infiltration)
排除标准
- •Prior treatment with radiopharmaceutical agents
- •HIV-associated lymphoma
- •Presence of human anti-mouse antibodies (HAMA) or anti-chimeric antibodies (HACA)
- •Patient's inability to follow the protocol
- •Hypersensitivity to 90Y-itritumomab tiuxetan
- •Presence of severe pathologies that preclude chemotherapeutic treatment
- •Pregnant women or pregnancy risk due to inappropriate contraceptive measures
- •Breastfeeding women
研究组 & 干预措施
1
Experimental
干预措施: Ibritumomab Tiuxetan (Zevalin) (Drug)
结局指标
主要结局
progression-free survival
时间窗: 12 months
次要结局
- acute and chronic Graft-versus-Host Disease(36 months)
- safety (toxicity, transplantation- and graft-related mortality)(36 months)
- response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007).(36 months)
- overall survival(36 months)
- relapse rate(36 months)
- the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival(36 months)
- haematological and immunological reconstitution, and chimerism.(Post transplantation. Once weekly until day +100 and every 2 weeks from day +100.)
研究者
研究点 (14)
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