NCT01062490已完成2 期
Clinical Phase II Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS)
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
- medac GmbH
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Efficacy: Evaluation of engraftment
研究概览
简要总结
This is a multicenter, multinational, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with MDS.
The aim is to demonstrate a clinical benefit compared to historical data with intravenous busulfan.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with myelodysplastic syndrome, (MDS) according to WHO classification (< 20 % myeloblasts in peripheral blood or bone marrow at initial diagnosis) indicated for allogeneic transplantation
- •Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) HLA-identity defined by the following markers: HLA-A, -B, -DRB1, DQB
- •Target graft size (unmanipulated) bone marrow: 2 to 10 x 106 CD34+ cells/kg BW recipient or at least 2 x 108 nucleated cells /kg BW or peripheral blood: 4 to 10 x 106 CD34+ cells/kg BW recipient
- •Age > 18 and < 60 years
- •Karnofsky Index > 80 %
- •Adequate contraception in female patients of child-bearing potential
- •Written informed consent
排除标准
- •'Secondary' or therapy-related MDS with known history of exposure to cytotoxic alkylating drugs and/or radiation therapy
- •Previous AML-induction therapy with more than two courses (e.g. in case of blast excess)
- •Previous allogeneic transplantation
- •Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function)
- •Known and manifested malignant involvement of the CNS
- •Active infectious disease
- •HIV- positivity or active hepatitis infection
- •Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit)
- •Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
- •Pleural effusion or ascites > 1.0 L
- •Pregnancy or lactation
- •Known hypersensitivity to treosulfan and/or fludarabine
- •Participation in another experimental drug trial within 4 weeks before study
- •Non-co-operative behaviour or non-compliance
- •Psychiatric diseases or conditions that might impair the ability to give informed consent
研究组 & 干预措施
Treosulfan
Experimental
Patients with myelodysplastic syndrome, (MDS) according to WHO classification (< 20 % myeloblasts in peripheral blood or bone marrow at initial diagnosis) indicated for allogeneic transplantation
干预措施: Treosulfan (Drug)
结局指标
主要结局
Efficacy: Evaluation of engraftment
时间窗: 4 years
Safety: Evaluation of CTC grade 3 and 4 adverse events between Day -6 and Day +28: hyperbilirubinemia and mucositis/stomatitis, veno-occlusive disease, seizures
时间窗: 4 years
次要结局
未报告次要终点
研究者
研究点 (1)
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