NCT00856505Unknown1 期
Everolimus and Mycophenolate Sodium as GvHD Prophylaxis in Allogeneic Stem Cell Transplantation
University Hospital Freiburg1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Toxicity according to CTCAE v3.0
研究概览
简要总结
In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:
- •acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse
- •chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis
- •myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML
- •Lymphoma:
- •plasmocytoma
- •immunocytoma (M. Waldenström)
- •chronic-lymphatic leukemia (CLL)
- •additional low and high grade Non-Hodgkin Lymphoma
- •Hodgkins disease
- •HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available
- •Signed informed consent
排除标准
- •CNS involvement by underlying disease
- •Pulmonary disease with VC < 55%, DLCO < 40%
- •Cardiac ejection fraction < 30%, uncontrollable arrhythmia
- •Creatinin > 1,5 mg/dl or Creatinin-Clearance < 30 ml/min
- •Bilirubin > 2 mg/dl
- •Active Hepatitis B or C
- •HIV serologic positive
- •Pregnancy and lactation
- •Pre-menstrual women without medical safe contraception
- •Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures.
- •Known allergy to study medication or ingredients of the formulation
- •Drug- or alcohol abuse
- •Non-compliance
研究组 & 干预措施
Everolimus and mycophenolate sodium
Experimental
Combination of experimental immunosuppressants for GvHD prophylaxis
干预措施: Everolimus and mycophenolate sodium (Drug)
结局指标
主要结局
Toxicity according to CTCAE v3.0
时间窗: after 100 days and one year after treatment start
次要结局
- Hematopoietic engraftment(day 30 after stem cell transplantation)
- Incidence of acute and chronic GvHD(one year after stem cell transplantation)
- Progression free survival(Day 100 and one year after stem cell transplantation)
- Overall survival(day 100 and one year after stem cell transplantation)
研究者
研究点 (1)
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相似试验
进行中（未招募）
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Everolimus and mycophenolate as GvHD-prophylaxis in the allogenous blood stem cell transplantation(Everolimus und Mycophenolsäure alsGvHD-Prophylaxe in der allogenen Blutstammzelltransplantation) - GvHD ProphylaxisProphylaxis of graft-versus-host disease after allogenous blood stem cell transplantationMedDRA version: 9.1Level: LLTClassification code 10018799Term: GVHDEUCTR2007-001892-12-DEniversity Medical Centre Freiburg
终止
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