A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT (IFN_BOSZT_01)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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