UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of etanercept for non-infectious lung complications after allogeneic stem cell transplantation
Acronym	Etanercept for non-infectious lung complications after allogeneic stem cell transplantation
Scientific Title	Efficacy and safety of etanercept for non-infectious lung complications after allogeneic stem cell transplantation
Scientific Title:Acronym	Etanercept for non-infectious lung complications after allogeneic stem cell transplantation
Region	Japan

Condition
Condition	Non-infectious lung complications after allogeneic stem cell transplantation
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate efficacy and safety of etanercept for patients with non-infectious lung complications after allogeneic stem cell transplantaion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary endpoint is the complete response rate at day 28 after administration of etanercept. The complete response rate is defined as the percentage of the patients with SpO2 93% or above on room air for 72 hours or above. The patients with SpO2 93% or above on room air after day 26 will be assessed after 72 hours from the achievement of SpO2 93% or above.
Key secondary outcomes	1. Response rate at day 28 after administration of etanercept The response rate is included in the complete response rate and the partial response rate. The partial response rate is defined as the percentage of the patients with SpO2 93% or above for 72 consecutive hours by at least 50% or below of oxygen support requirements before the start of treatment. 2. Duration from the start of treatment until the first day of independent of oxygen support for 72 hours 3. Overall survival at day 28 and 1 year after the start of treatment 4. Adverse effect such as infection and reaction on injection site, laboratory data and the results of X-ray and CT scan 5. The levels of cytokines prior to administration of etanercept, at day 15 days and day 29 after treatment, and the association between these data and response rate 6.The association between patient characteristics and response rate

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Etanercept is administered subcutaneously at a dose of 25mg/body, twice weekly (72-96 hours between doses), for total of 8 doses (4-week course).
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients older than 16 years 2. Signed informed consent by patients themselves or their proxies to participate as a subject in this study 3. Patients with non-infectious lung complications after allogeneic stem cell transplantation and an oxygen saturation (SpO2) 93% or below in room air or 93% or above in inhaled oxygen
Key exclusion criteria	1. Patients who do not consent to this study 2. Patients considered ineligible for this study by physicians
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Miwa Middle name Last name Adachi
Organization	Hamamatsu university school of medicine
Division name	Department of hematology
Zip code	431-3192
Address	1-20-1 Hanndayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	0534352111
Email	takaono@hama-med.ac.jp

Public contact
Name of contact person	1st name Miwa Middle name Last name Adachi
Organization	Hamamatsu university school of medicine
Division name	Department of hematology
Zip code	431-3192
Address	1-20-1 Hanndayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL	053-435-2267
Homepage URL
Email	m.adachi@hama-med.a.cjp

Sponsor
Institute	Department of hematology, Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization	Department of hematology, Hamamatsu university school of medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hamamatsu university school of medicine
Address	1-20-1 Handayama
Tel	0534352111
Email	rinri@hama-med.ac.jp

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	2018 Year 06 Month 01 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	Terminated
Date of protocol fixation	2018 Year 01 Month 09 Day
Date of IRB	2020 Year 04 Month 07 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 28 Day
Last modified on	2021 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036924