UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation
Acronym	Etanercept for IPS after allogeneic HSCT
Scientific Title	An exploratory study of administration of Etanercept for patients with idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell trasnplantation
Scientific Title:Acronym	Etanercept for IPS after allogeneic HSCT
Region	Japan

Condition
Condition	idiopathic pneumonia syndrome after allogeneic hematopoietic stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy and safety of etanercept for IPS after hematopoietic stem cell transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	withdrawal rate from oxygenation
Key secondary outcomes	1-year overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Subcutaneous administration of etanercept, 0.4 mg/kg (max 25 mg) 2 times a week for four weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who have received allogeneic hematopoietic stem cell transplantation. (2) Patients with IPS. NIH criteria for IPS (a) multilobar infiltrates on CXR or CT. (b) Clinical signs of pneumonia: cough, dyspnea, or rales. (c) Abnormal physiology: increased arterial-alveolar oxygen gradient, or the need for supplemental oxygen support. (d) Negative BAL for bacterial and nonbacterial organisms. (e) Negative surgical lung biopsy. (a), (b) and (c) were all fulfilled and (d) or (e) was also fulfilled. (3) patients equal or older than 20 yo. (4) written informed consent was obtained.
Key exclusion criteria	(1) patients without enough . (2) the presence of any of the following after at the time of enrollment. (a) an active pulmonary infection as determined by positive culture of bronchoalveolar lavage (BAL) fluid. (b) hypotension in which inotropic support other than dopamine was required. (c) bacteremia within 48 hours before study entry. (d) CMV viremia. (e) systemic fungal or other nonbacterial infections. (f) clinical or echocardiographic evidence for cardiac dysfunction as the cause of respiratory failure. (3) pregnancy or lactating.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Honda
Organization	Univesity of Tokyo Hospital
Division name	Hematology and Oncology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	ahonda-spr@umin.org

Public contact
Name of contact person	1st name Middle name Last name Akira Honda
Organization	Univesity of Tokyo Hospital
Division name	Hematology and Oncology
Zip code
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	ahonda-spr@umin.org

Sponsor
Institute	Univesity of Tokyo Hospital, Department of Hematology and Oncology
Institute
Department

Funding Source
Organization	None.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 08 Day
Date of IRB	2009 Year 10 Month 08 Day
Anticipated trial start date	2009 Year 10 Month 08 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 05 Month 31 Day
Date analysis concluded	2020 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 29 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020548