UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032737 |
|---|---|
| Receipt number | R000036924 |
| Scientific Title | Efficacy and safety of etanercept for non-infectious lung complications after allogeneic stem cell transplantation |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/11/29 16:20:01 |
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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
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
m.adachi@hama-med.a.cjp
Sponsor or person
Institute
Department of hematology, Hamamatsu university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036924
