Steroid-refractory Bronchiolitis Obliterans
Conditions
Keywords
steroid-refractory, bronchiolitis obliterans, allogeneic stem cell transplantation, interferon gamma
Brief summary
Improvement of quality of life in patients with BO and establishment of a new third line therapy
Detailed description
Primary Objectives: Objective improvement of lung function, i.e.: * Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients ≥ 20 % or * Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant parameters at blood gas analysis (BGA) or * Improvement of obstructive parameters ≥ 20 % or * Improvement of lung function score (LFS) at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks. Secondary Objectives * Morphological improvement of BO/BOOP at CT scan * Reduction of steroids about at least 20 %
Interventions
Initial dose: 50µg s.c. three times/week, without fever \>38,5 dose increase: 50µg/m² BSA three times/week
Sponsors
ClinAssess GmbH
University Hospital Regensburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Allogeneic SCT * Age ≥ 18 years * BO, firmed by 2 out of 3 examinations: * Lung function/ BGA * CT scan in in- and expiration or * Histological diagnosis * Therapy refractory BO, i.e. no improvement during at least three therapies, among: * Azithromycin + inhaled steroids/ bronchodilators * Systemic steroids 1 mg/kg BW * One 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, defined as ANC \> 1000/ml, platelets \> 50/nl and haemoglobin \> 8 g/dl * Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) lower than 3 x paramount normal range * Kreatinin lower than 3 x paramount normal range * Informed consent
Exclusion criteria
* 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) higher than 3 x paramount normal range * Kreatinin higher than 3 x paramount normal range * Participation in another study within 4 weeks before or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| therapy response | 24 weeks | Enhancement of therapy response from 15 % to 50 % |
Countries
Germany
Outcome results
None listed