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

Sponsor:

Collaborator:

ClinAssess GmbH

Information provided by (Responsible Party):

Professor Ernst Holler MD, University Hospital Regensburg

Study Description

Brief Summary:

Improvement of quality of life in patients with BO and establishment of a new third line therapy

Condition or disease	Intervention/treatment	Phase
Steroid-refractory Bronchiolitis Obliterans	Drug: Interferon gamma 1b	Phase 2

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 %

Study Design


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

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon Interferon Gamma-1b

Genetic and Rare Diseases Information Center resources: Bronchiolitis Obliterans

U.S. FDA Resources

Arms and Interventions

Intervention Details:

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

Other Name: Imukin

Outcome Measures

Primary Outcome Measures :

therapy response [ Time Frame: 24 weeks ]
Enhancement of therapy response from 15 % to 50 %

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Germany
University Hospital Regensburg
Regensburg, Germany, 93053

Sponsors and Collaborators

University Hospital Regensburg

ClinAssess GmbH

Investigators


Principal Investigator:	Ernst Holler, Professor MD	University Hospital Regensburg

More Information


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

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