NCT00646750已完成2 期
Autologous Transplantation of Haematopoietic Stem Cells With Conditioning Including Zevalin + BEAM to Patients Suffering From Refractory Large B-cell Diffuse Lymphom
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea18 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2008年1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
- 31
- 试验地点
- 18
- 主要终点
- Disease clinical response to treatment - complete response rate.
研究概览
简要总结
To evaluate the efficacy (complete response rate) of Ybritumomab Tiuxetan (Zevalin) administration in the conditioning treatment of patients with refractory large B-cell diffuse lymphoma submitted to autologous transplantation of peripheral blood haematopoietic stem cells.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give their written informed consent.
- •Abide by at least one of the following conditions:
- •Obtain no partial response after first-line chemotherapy including anthracyclines + rituximab (R-CHOP, R-MegaCHOP, R-EPOCH or the like), or else
- •Absence of partial response after having received salvage (post-induction) chemotherapy including R-IFE, R-ESHAP, R-ICE or the like.
- •Patients on first recidivation who do not attain partial remission after salvage chemotherapy.
- •Patients with transformed lymphoma, on first partial remission (No CR).
- •Stable disease at the time of transplantation.
- •Age ≥ 18 but ≤
- •Life expectancy of greater than three months.
- •Additionally, to be able to undergo haematopoietic stem cell transplantation, all patients should satisfy the requirements of routine clinical practice, i.e.:
- •Performance status (ECOG) <
- •FEV1, DLCO and FVC ≥ 50% of the normal theoretical values.
- •Ventricular ejection fraction (through echocardiography or isotope ventriculography) ≥ 50%.
- •Total bilirubin and transaminases < 3 times the normal maximum value, except if attributable to the underlying disease.
- •Creatinine < 2 times the maximum normal value, and creatinine clearance > 40 ml/min, except if attributable to the underlying disease.
- •Absence of symptomatic heart disease, cirrhosis or active B or C virus hepatitis.
- •HIV negative.
排除标准
- •Impossibility of collecting, via apheresis, a number of CD34+ cells ≥ 2 x 106/kg.
- •Known hypersensitivity to mouse proteins.
- •Involvement of CNS by lymphoma.
- •Progressive lymphoma during the month prior to the date of transplantation.
- •Previous radioimmunotherapy.
- •Previous autologous transplantation of haematopoietic stem cells.
- •Pregnant or breastfeeding women, or adults of childbearing age who are not using an effective contraceptive method.
- •Being submitted to treatment in a clinical trial for 30 days prior to entry in this trial.
- •Active psychiatric disease, including addiction disorders.
- •Existence of active not-haematopoietic neoplasia, with the exception of cutaneous basal carcinoma or cervix intraepithelial carcinoma.
研究组 & 干预措施
1
Experimental
BEAM preceded by Ybritumomab Tiuxetan (Zevalin)
干预措施: Ybritumomab Tiuxetan (Zevalin); Rituximab; BEAM (BCNU, ARAC, VP16 and Melphalan) (Drug)
结局指标
主要结局
Disease clinical response to treatment - complete response rate.
时间窗: Pre-transplantation; post-transplantation (one week following Ybritumomab Tiuxetan (Zevalin) administration); And three months post-transplantation
次要结局
- Haematopoietic and extra-haematopoietic toxicity of the Ybritumomab Tiuxetan (Zevalin) plus BEAM regimen.(36 months)
- Overall response rate (complete + partial response)(36 month)
- Overall survival(96 months)
- Post-transplantation haematological and immunological reconstitution(Until post-transplantation day +100)
- Progression-free-survival(36 month)
研究者
研究点 (18)
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