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

NCT01639261 | Unknown Phase 2

• 2 other identifiers: IFN_BOSZT_012010-022467-36
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Steroid-refractory Bronchiolitis Obliterans

Keywords

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

Outcome Measures

Primary Outcomes (1)

• therapy response

  Enhancement of therapy response from 15 % to 50 %

  24 weeks

Interventions

Interferon gamma 1b DRUG

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

Also known as: Imukin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Regensburg: lead
• ClinAssess GmbH: collaborator

Study Sites (1)

University Hospital Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Study Officials

• Ernst Holler, Professor MD

  University Hospital Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: September 1, 2014
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

DE (1)