A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT (IFN_BOSZT_01)

University Hospital Regensburg

Status and phase: Unknown; Phase 2

Conditions: Steroid-refractory Bronchiolitis Obliterans

Treatments: Drug: Interferon gamma 1b

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01639261

IFN_BOSZT_01

2010-022467-36 (EudraCT Number)

Details and patient eligibility

About

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

Full 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 %

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)