A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy

• Register: EUCTR
• Last refreshed on: 7 April 2015
• Main ID: EUCTR2010-022467-36-DE
• Date of registration: 22/06/2011
• Prospective Registration: Yes
• Primary sponsor: Freistaat Bayern
• Public title: A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy
• Scientific title: A phase II study about interferon gamma 1b to therapy the steroid-refractory bronchiolitis obliterans after allogenic stem cell therapy
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022467-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Contacts

• Name: Heike Kassubek
• Affiliation: Klinikum der Universität Regensburg

• Name: Heike Kassubek
• Affiliation: Klinikum der Universität Regensburg

Key inclusion & exclusion criteria

Inclusion criteria:
• Allogeneic SCT
• Age = 18 years
• BO, firmed by 2 out of 3 examinations:
o Lung function/ BGA
o CT scan in in- and exspiration or
o Histological diagnosis
• Therapy refractory BO, i.e. no improvement during at least three therapies, among:
o Azithromycin + inhaled steroids/ bronchodilatators
o Systemic steroids 1 mg/kg BW
o 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 or cytopenia, defined as ANC > 1000/ml, platelets > 50/nl and haemoglobin > 8 g/dl
• Liver parameters (bilirubin, gammaGT, AP, ASAT, ALAT) below 3x normal range
• Creatinin below 3x normal range
• Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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) above 3x normal range
• Creatinin above 3x normal range
• Participation in another study within 4 weeks before or during the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

steroid-refractory bronchiolitis obliterans
MedDRA version: 13.1 Level: PT Classification code 10029888 Term: Obliterative bronchiolitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Trade Name: Imukin
Product Name: Imukin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon gamma-1b
CAS Number: 98059-61-1
Current Sponsor code: Imukin
Other descriptive name: INTERFERON GAMMA-1B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,1-

Primary Outcome(s)

Main Objective: Objective improvement of lung function, i.e.:
• Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in ventilated patients = 20 %
or
• Reduction of oxygen need in oxygen dependent patients = 1L O2/min without deterioration of parameters in 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.

Timepoint(s) of evaluation of this end point: for all 4 weeks until week 24

Primary end point(s): lung function testing, blood gas analysis

Secondary Objective: • Morphological improvement of BO/BOOP at CT scan
• Reduction of steroids (dose/day) about at least 20 %

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: CT: after 12 and 24 weeks
reduction of steroid: for all 4 weeks until week 24

Secondary end point(s): CT, reduction of steroids about at least 20 %

Secondary ID(s)

IFN_BOSZT_01

Source(s) of Monetary Support

Klinikum der Universität Regensburg