A Phase II Trial on Treatment of Steroid-refractory Bronchiolitis Obliterans With Interferon Gamma 1b After Allogeneic SCT (IFN_BOSZT_01)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital Regensburg.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University Hospital Regensburg
Collaborator:
ClinAssess GmbH
Information provided by (Responsible Party):
Professor Ernst Holler MD, University Hospital Regensburg
ClinicalTrials.gov Identifier:
NCT01639261
First received: July 9, 2012
Last updated: July 11, 2012
Last verified: July 2012
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Purpose
Improvement of quality of life in patients with BO and establishment of a new third line therapy
| Condition | Intervention | Phase |
|---|---|---|
|
Steroid-refractory Bronchiolitis Obliterans |
Drug: Interferon gamma 1b |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT |
Resource links provided by NLM:
Further study details as provided by University Hospital Regensburg:
Primary Outcome Measures:
- therapy response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Enhancement of therapy response from 15 % to 50 %
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Interferon gamma 1b
Initial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week
Other Name: Imukin
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01639261
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639261
Locations
| Germany | |
| University Hospital Regensburg | |
| Regensburg, Germany, 93053 | |
Sponsors and Collaborators
University Hospital Regensburg
ClinAssess GmbH
Investigators
| Principal Investigator: | Ernst Holler, Professor MD | University Hospital Regensburg |
More Information
| Responsible Party: | Professor Ernst Holler MD, Senior physician, University Hospital Regensburg |
| ClinicalTrials.gov Identifier: | NCT01639261 History of Changes |
| Other Study ID Numbers: | IFN_BOSZT_01 2010-022467-36 |
| Study First Received: | July 9, 2012 |
| Last Updated: | July 11, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University Hospital Regensburg:
|
steroid-refractory bronchiolitis obliterans allogeneic stem cell transplantation interferon gamma |
Additional relevant MeSH terms:
|
Bronchiolitis Obliterans Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Tract Infections Interferons Interferon-gamma Antineoplastic Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 26, 2016