UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021349 |
|---|---|
| Receipt number | R000024619 |
| Scientific Title | Feasibility of Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a pilot study. |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2017/03/12 16:31:10 |
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Basic information
Public title
Feasibility of Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a pilot study.
Acronym
Feasibility of Ruxolitinib in steroid-refractory GVHD
Scientific Title
Feasibility of Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a pilot study.
Scientific Title:Acronym
Feasibility of Ruxolitinib in steroid-refractory GVHD
Region
| Japan |
Condition
Condition
corticosteroid-refractory graft-versus-host disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of Ruxolitinib therapy for steroid-refractory GVHD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rete of GVHD
adverse effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ruxolitinib 5mg, twice a day
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
steroid refractory GVHD
age; 20-70 years
Key exclusion criteria
1) with active infection
2) w/o informed consent
3) CCr<10 ml/min
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Harigae |
Organization
Tohoku University Hospital
Division name
Hematology-Rhumatology
Zip code
Address
1-1 Seiryo-machi, Sendai
TEL
022-717-7165
harigae@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Onishi |
Organization
Tohoku University Hospital
Division name
Hematology-Rhumatology
Zip code
Address
1-1 Seiryo-machi, Sendai
TEL
022-717-7165
Homepage URL
yonishi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Address
Tel
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
| 2016 | Year | 03 | Month | 07 | 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
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2017 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024619
