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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)

Primary Purpose

Steroid-refractory Bronchiolitis Obliterans

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Interferon gamma 1b
Sponsored by
University Hospital Regensburg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Steroid-refractory Bronchiolitis Obliterans focused on measuring steroid-refractory, bronchiolitis obliterans, allogeneic stem cell transplantation, interferon gamma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Regensburg

Outcomes

Primary Outcome Measures

therapy response
Enhancement of therapy response from 15 % to 50 %

Secondary Outcome Measures

Full Information

First Posted
July 9, 2012
Last Updated
July 11, 2012
Sponsor
University Hospital Regensburg
Collaborators
ClinAssess GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01639261
Brief Title
A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT
Acronym
IFN_BOSZT_01
Official Title
Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Regensburg
Collaborators
ClinAssess GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steroid-refractory Bronchiolitis Obliterans
Keywords
steroid-refractory, bronchiolitis obliterans, allogeneic stem cell transplantation, interferon gamma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interferon gamma 1b
Other Intervention Name(s)
Imukin
Intervention Description
Initial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week
Primary Outcome Measure Information:
Title
therapy response
Description
Enhancement of therapy response from 15 % to 50 %
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst Holler, Professor MD
Organizational Affiliation
University Hospital Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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