A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT

Study Overview
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Brief Summary
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Improvement of quality of life in patients with BO and establishment of a new third line therapy

Detailed Description
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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 %

Official Title
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Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT

Conditions
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Steroid-refractory Bronchiolitis Obliterans

Intervention / Treatment
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* Drug: Interferon gamma 1b


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon gamma 1b|Initial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapy response | Enhancement of therapy response from 15 % to 50 % | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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steroid-refractory, bronchiolitis obliterans, allogeneic stem cell transplantation, interferon gamma