EUCTR2006-003683-54-DE进行中（未招募）不适用
Prospektive, offene, randomisierte, multizentrische Studie zur Effektivität von Palifermin in der Prophylaxe der Mukositis nach allogener Stammzelltransplantation mit myeloablativer Granzkörperbestrahlung
GMIHO Gesellschaft für medizinische Innovation/Hämatologie und Onkologie mbH0 个研究点开始时间: 2008年5月16日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-age >= 18 years
- •-general condition ECOG WHO <=2
- •-life expectancy over three months
- •-total body irradiation with 10 to 12 Gy total body dosis with a lung dosis of 8 Gy fractionated, in combination with high dose chemotherapy (120 mg/kg body weight cyclophosphamid i.v.)and optional for unrelated donors administration of antithymocyte globulin before application of the graft
- •-allogeneic stem cell transplantation (bone marrow or blood stem cells) with al HLA-compatible donor with a minimum of 8 out of 10 compatible HLA-class-I (A,B,C) or -II
- •(DR,DQ) compatibility
- •-acute or chronic leukemia with an indication for an allogenic stem cell transplantation
- •-graft-versus-host prophylaxis with cyclosporin A or tacrolismus in a combination with or without mycophenolat or methotrexat
- •-women of childbearing potential must us an high effictive method for contraception
- •-negativ pregnancy test
- •-signed informed consent of the patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-contraindication for allogenic stem cell transplantation
- •-dose-reduced conditioning with <= 8 Gy total body irradation dose
- •-haploid stem cell donor
- •-pregnant or lactating women
- •-women of childbearing potential not using a high effective method for contraception
- •-pre-medication with palifermin
- •-hypersensitivity against palifermin, one of its contents or proteins derived from eschericia coli
- •-no signed informed consent of the patient
研究者
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