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

• Conditions: steroid-refractory bronchiolitis obliterans; MedDRA version: 13.1Level: PTClassification code 10029888Term: Obliterative bronchiolitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-022467-36-DE
• Lead Sponsor: Freistaat Bayern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-22
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•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

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) above 3x normal range
•Creatinin above 3x normal range
•Participation in another study within 4 weeks before or during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective improvement of lung function, i.e.:<br>•Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in ventilated patients = 20 %<br> or<br>•Reduction of oxygen need in oxygen dependent patients = 1L O2/min without deterioration of parameters in blood gas analysis (BGA)<br> or<br>•Improvement of obstructive parameters = 20 %<br> or<br>•Improvement of lung function score (LFS) at least about one grade<br>Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks.<br>;Secondary Objective: •Morphological improvement of BO/BOOP at CT scan <br>•Reduction of steroids (dose/day) about at least 20 %<br>;Primary end point(s): lung function testing, blood gas analysis;Timepoint(s) of evaluation of this end point: for all 4 weeks until week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): CT, reduction of steroids about at least 20 %;Timepoint(s) of evaluation of this end point: CT: after 12 and 24 weeks<br>reduction of steroid: for all 4 weeks until week 24