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. The completion date has passed and the status has not been verified in more than two years.

Verified July 2012 by Professor Ernst Holler MD, 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

History of Changes

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:	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:

Drug Information available for: Interferon Interferon Gamma-1b

Genetic and Rare Diseases Information Center resources: Bronchiolitis Obliterans

U.S. FDA Resources

Further study details as provided by Professor Ernst Holler MD, University Hospital Regensburg:

Primary Outcome Measures:

therapy response [ Time Frame: 24 weeks ]
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:

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 (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

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


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 )
Study First Received:	July 9, 2012
Last Updated:	July 11, 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

ClinicalTrials.gov processed this record on June 23, 2017

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