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

Steroid-refractory Bronchiolitis Obliterans Clinical Trial

— IFN_BOSZT_01  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01639261
• Other study ID #: IFN_BOSZT_01
• Secondary ID: 2010-022467-36
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 9, 2012
• Last updated: July 11, 2012
• Start date: July 2012
• Est. completion date: September 2014

Study information

• Verified date: July 2012
• Source: University Hospital Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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 %

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Steroid-refractory Bronchiolitis Obliterans

Intervention

Drug:
• Interferon gamma 1b
Initial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week

Locations

Country	Name	City	State
Germany	University Hospital Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Regensburg	ClinAssess GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	therapy response	Enhancement of therapy response from 15 % to 50 %	24 weeks	No