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

NCT ID: NCT01639261

Last Updated: 2012-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-09-30

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 %

Conditions

Steroid-refractory Bronchiolitis Obliterans

Keywords

steroid-refractory; bronchiolitis obliterans; allogeneic stem cell transplantation; interferon gamma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Interferon gamma 1b

Initial dose: 50µg s.c. three times/week, without fever \>38,5 dose increase: 50µg/m² BSA three times/week

Intervention Type: DRUG

Other Intervention Names

Imukin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinAssess GmbH

INDUSTRY

Sponsor Role: collaborator

University Hospital Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Professor Ernst Holler MD

Senior physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernst Holler, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Regensburg

Locations

University Hospital Regensburg

Regensburg, , Germany

Countries

Germany

Other Identifiers

2010-022467-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IFN_BOSZT_01

Identifier Type: -

Identifier Source: org_study_id