NCT00750126Unknown2 期
Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary criterion - Hematological reconstitution and chimerism post-transplantation
研究概览
简要总结
To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation chimerism and hematological reconstitution.
To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.
To study overall survival.
详细描述
Primary criterion
- Hematological reconstitution and chimerism post-transplantation
Secondary criteria
- Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
- Analysis of variations in post-transplantation immunological function profiles
- Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients
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
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged less than 20 years old
- •Lansky score > 60%
- •Life expectancy greater than 2 months
- •Diagnoses:
- •3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
- •4- Malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning.
- •Usual criteria for allogeneic grafting (pre-graft profile)
- •Having a HLA-identical sibling donor for HLA-A, HLA-B and HLA-DR antigens or a HLA mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood.
- •Signed informed consent
排除标准
- •Patient presenting rapidly-progressive malignancy
- •In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
- •Unable to sufficiently understand the treatment and its consequences, even after explanation
结局指标
主要结局
Primary criterion - Hematological reconstitution and chimerism post-transplantation
时间窗: post-transplantation
次要结局
- Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions(post-transplantation)
研究者
研究点 (2)
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