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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital Regensburg.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ClinAssess GmbH
Information provided by (Responsible Party):
Professor Ernst Holler MD, University Hospital Regensburg
ClinicalTrials.gov Identifier:
NCT01639261
First received: July 9, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Steroid-refractory Bronchiolitis Obliterans
Drug: Interferon gamma 1b
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT

Resource links provided by NLM:


Further study details as provided by University Hospital Regensburg:

Primary Outcome Measures:
  • therapy response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Enhancement of therapy response from 15 % to 50 %


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
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 %
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 9, 2012
Last Updated: July 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Regensburg:
steroid-refractory
bronchiolitis obliterans
allogeneic stem cell transplantation
interferon gamma

Additional relevant MeSH terms:
Bronchiolitis Obliterans
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Interferon-gamma
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014