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

July 11, 2012 updated by: Professor Ernst Holler MD, University Hospital Regensburg

Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93053
        • University Hospital Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
therapy response
Time Frame: 24 weeks
Enhancement of therapy response from 15 % to 50 %
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Regensburg

Collaborators

ClinAssess GmbH

Investigators

  • Principal Investigator: Ernst Holler, Professor MD, University Hospital Regensburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (ESTIMATE)

July 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFN_BOSZT_01
  • 2010-022467-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Steroid-refractory Bronchiolitis Obliterans

Clinical Trials on Interferon gamma 1b

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe