A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT (IFN_BOSZT_01)
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ClinicalTrials.gov Identifier: NCT01639261 |
Recruitment Status
: Unknown
Verified July 2012 by Professor Ernst Holler MD, University Hospital Regensburg.
Recruitment status was: Active, not recruiting
First Posted
: July 12, 2012
Last Update Posted
: July 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Steroid-refractory Bronchiolitis Obliterans | Drug: Interferon gamma 1b | Phase 2 |
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 %
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | September 2014 |
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Drug: Interferon gamma 1b
- therapy response [ Time Frame: 24 weeks ]Enhancement of therapy response from 15 % to 50 %

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Allogeneic SCT
- Age ≥ 18 years
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BO, firmed by 2 out of 3 examinations:
- Lung function/ BGA
- CT scan in in- and expiration or
- Histological diagnosis
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639261
Germany | |
University Hospital Regensburg | |
Regensburg, Germany, 93053 |
Principal Investigator: | Ernst Holler, Professor MD | University Hospital Regensburg |
Responsible Party: | Professor Ernst Holler MD, Senior physician, University Hospital Regensburg |
ClinicalTrials.gov Identifier: | NCT01639261 History of Changes |
Other Study ID Numbers: |
IFN_BOSZT_01 2010-022467-36 ( EudraCT Number ) |
First Posted: | July 12, 2012 Key Record Dates |
Last Update Posted: | July 12, 2012 |
Last Verified: | July 2012 |
Keywords provided by Professor Ernst Holler MD, University Hospital Regensburg:
steroid-refractory bronchiolitis obliterans allogeneic stem cell transplantation interferon gamma |
Additional relevant MeSH terms:
Bronchiolitis Obliterans Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Tract Infections Interferons Interferon-gamma Antineoplastic Agents Antiviral Agents Anti-Infective Agents |