Tansfusion of granulocytes for patients with febrile neutropenia - GRANITE

niversität zu Köln0 个研究点目标入组 100 人开始时间: 2011年5月4日最近更新: 2024年8月19日

适应症

试验速览

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•valid informed consent, subscribed by patient or his/her attorney
•One of the following diseases:
•- C92.0- acute myeloid leukaemia,
•- C91.0- acute lymphoblastic leukaemia,
•- C92.1- chronic myeloid leukaemia,
•- C91.1- chronic lymphatic leukaemia,
•- D46.9 myelodysplastic syndrome, unspecified,
•- D47.1 chronic myeloproliferative disease,
•- C82.- follicular (nodular) non-Hodgkin's lymphoma
•- C83.- diffuse non-Hodgkin's lymphoma
•- C84.4 peripheral T-cell lymphoma
•- C90.0- Multiple myeloma
•- C81.9 Hodgkin's lymphoma
•Karnofsky Performance Status > 20%
•echocardiography: ejection-fraction > 40%
•creatinine clearance > 60ml/min
•Pulmonary function: oxygensaturation at least 80%
•therapy-refractory fever above 38°C without response to standard-therapy for 96 hours

•symptomatic coronary heart disease
•cardial insuffiency NYHA III or IV
•lungdisease with dyspnoea WHO III or IV
•oxygensaturation < 80%
•severe therapy-refractory arterial hypertension
•non-therapy-induced neutropenia (e.g. aplastic anemia)
•active psychiatric disease
•severe kidney-dysfunction (creatinine-clearance < 60 ml/min)
•severe hepatic-dysfunction with bilirubin > 2 mg/dl
•insufficient therapy of a thyroid-dysfunction (T3/T4 out of the reference range)
•Pregnancy or lactation
•Noncontrollable life-threatening bleeding
•Intracerebrally process leading to an increase of intracranial pressure (bleeding, infectious disease, tumour)
•cerebral convulsions
•Karnofsky Performance Status < 20%
•participation in the clinical trial in the last 30 days
•medical or psychic condition, which does nor allow the patient to participate in the clinical trial, neither subscribe an informed consent, according to a doctor's opinion

发起方

niversität zu Köln