Clinical trial NCT01639261: A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT
Official title: Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Steroid-refractory Bronchiolitis Obliterans
Keywords: steroid-refractory
bronchiolitis obliterans
allogeneic stem cell transplantation
interferon gamma
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
Collaborators: name: ClinAssess GmbH
First posted: 2012-07-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 %

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

Primary outcomes:
measure: therapy response
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: University Hospital Regensburg
name: Ernst Holler, Professor MD
role: PRINCIPAL_INVESTIGATOR
References: