A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy

Freistaat Bayern0 个研究点开始时间: 2011年6月22日最近更新: 2015年4月7日

适应症

试验速览

暂无简介。

•Allogeneic SCT
•Age = 18 years
•BO, firmed by 2 out of 3 examinations:
•oLung function/ BGA
•oCT scan in in- and exspiration or
•oHistological diagnosis
•Therapy refractory BO, i.e. no improvement during at least three therapies, among:
•oAzithromycin + inhaled steroids/ bronchodilatators
•oSystemic steroids 1 mg/kg BW
•oOne of the following therapies: MMF, mTOR inhibitors or ECP
•Effective contraception (before, during and for 8 weeks after the treatment)
•Blood count: no severe neutropenia or cytopenia, defined as ANC > 1000/ml, platelets > 50/nl and haemoglobin > 8 g/dl
•Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) below 3x normal range
•Creatinin below 3x normal range
•Informed consent
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Age < 18 years
•Pregnant or nursing woman
•No appropriate contraception
•Participation in any other study within 4 weeks before or during the study
•Active acute GvHD of other organs than the lung > grade II or severe active chronic GvHD
•No appropriate antibiotic/ antimycotic therapy in documented infection
•Severe bone marrow suppression (ANC < 1000/ml) or graft failure
•Liver parameters (bilirubin, gammaGT, AP, ASAT and ALAT) above 3x normal range
•Creatinin above 3x normal range
•Participation in another study within 4 weeks before or during the study

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