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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

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 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



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


Primary Outcome Measures :
  1. 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, 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

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

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