GRANITE-1 - Granulocyte-transfusions for patients with febrile neutropenia - GRANITE

niversity of Cologne0 个研究点目标入组 200 人开始时间: 2010年4月22日最近更新: 2021年4月5日

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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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•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

niversity of Cologne