EUCTR2007-001892-12-DE进行中（未招募）不适用
Everolimus and mycophenolate as GvHD-prophylaxis in the allogenous blood stem cell transplantation(Everolimus und Mycophenolsäure alsGvHD-Prophylaxe in der allogenen Blutstammzelltransplantation) - GvHD Prophylaxis
niversity Medical Centre Freiburg0 个研究点开始时间: 2007年6月12日最近更新:
适应症
相关药物
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
- •1.Acute myeloid leukemia (AML), not curable by chemotherapy alone; patient with CR1, = CR2, primary refractory, with relapse
- •2.Chronic myeloid leukemia (CML) in chronic phase, if no response to imatinib is documented; in acceleration or blast crisis
- •3.Myelodysplastic yyndromes (MDS) in the advanced stages RA, RARS (transfusions required), RAEB, RAEB-t and CMML.
- •4.Lymphomas that require further treatment after standard primary and relapse therapy erneut:
- •? Plasmocytoma
- •? Immunocytoma (M. Waldenström)
- •? Chronic lymphatic leukemia (CLL)
- •? follicular and highly malignant Non-Hodgkin lymphoma
- •5.Morbus Hodgkin
- •6.Karnofsky scale > 60 %
- •7.Compatibility of matched family or matched unrelated donor (HLA-A-, -B-, -DRB1-Kompatibilität)
- •8.Written informed consent
- •1.Age < 75 years
- •2.No suspicion in health status and laboratory
- •3.Informed consent to G-CSF intake and leukapharesis and implantation of temporary central venous catheters
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Disease involves CNS
- •2. Pulmonary disease with VC < 55%, DLCO < 40%
- •3. Cardiac ejection fraction < 30%, uncontrolled malignant arrhythmia
- •4. creatinine > 1,5 mg/dl and/or creatinine clearance < 30 ml/min
- •5. Bilirubine > 2 mg/dl
- •6. Florid systemic infection (esp. hepatitis B or C)
- •7. Sero-positive patient for HIV
- •8. Pregnancy and lactation
- •9. Women of child bearing potential without sufficient contrazeption
- •10. Participation in a clinical trial within the last 30 days prior to this study and/or simultaneous participation in another clinical trial for evaluation of pharmaceutical products. The participation in studies with epidemiological objectives or investigations of diagnostic or supportive procedures is allowed as far as they do not interfere with the objectives of this trial.
- •11. Known drug or alcohol abusus
- •12. Patient who is not able to give informed consent
- •13. Hypersensitivity against everolimus, sirolimus or against one of the other ingredients of certican(r) tablets (butylhydroxytoluol, magnesia-stearat, lactose-monohydrate, hypromellose, crospovidone, lactose)
- •14. Hypersensitivity against mycophenolate-mophetil, mycophenolate, mycophenolate-sodium or against one of the other ingredients of myfortic(r) film tablets (cornstarch, povidone, silicium-dioxide, hypromellosephthalat,e titandioxide [E 171], ferrum(III)-hydroxide-oxide [E 172], indigocarmine [E 132], ferrum(III)-oxide [E 172]
- •15. Vaccination with attenuated live vaccine within the last 30 days
- •16. Hereditary disease (e.g. galactose intolerance, Lapp-lactase-lack, glucose-galactose-malabsorption, lack of hypoxanthine-guanine-phosphsribosyl-transferase [e.g. Lesch-Nyhan- and Kelley-Seegmiller-syndrome])
- •17. Hypersensitivity against mycophenolatmophetil and alemtuzumab
- •18. active tumor disease
- •19. uncontrolled ischemic heart disease
- •1. Pregnancy
- •2. Sero-positive patient for HIV or Hbs antigen
研究者
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