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

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Regensburg
• Collaborator: ClinAssess GmbH
• Treatments: Interferon-gamma; Interferons

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