UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024497 |
|---|---|
| Receipt number | R000028194 |
| Scientific Title | Phase I clinical trial of WT1 vaccination for MDS with dose escalation |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2018/04/23 12:43:23 |
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Basic information
Public title
Phase I clinical trial of WT1 vaccination for MDS with dose escalation
Acronym
Phase I clinical trial of WT1 vaccination for MDS
Scientific Title
Phase I clinical trial of WT1 vaccination for MDS with dose escalation
Scientific Title:Acronym
Phase I clinical trial of WT1 vaccination for MDS
Region
| Japan |
Condition
Condition
MDS
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety of WT1 vaccination in MDS patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequencies of adverse events (Grade3,4)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intradermal injection of WT1 peptides biweekly
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
Patients diagnosed as MDS
HLA-A2402
Elevated WT1 expression in peripheral blood or bone marrow
Key exclusion criteria
Dysfunction of major organs
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Sugiyama |
Organization
Osaka University
Division name
Cancer Immunoligy
Zip code
Address
1-7, yamada-Oka, Suita
TEL
0668792597
sugiyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hosen |
Organization
Osaka University Graduate School of Medicine
Division name
Cancer Stem Cell Biology
Zip code
Address
1-7, Yamada-Oka
TEL
0668793676
Homepage URL
hnaoki@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Dept of Cancer Immunology
Institute
Department
Personal name
Funding Source
Organization
Dept of Cancer Immunotherapy, Osaka Univ.
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 | 10 | Month | 20 | 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 | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028194
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
