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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024497
Receipt No. 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

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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
Email 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
Email hnaoki@imed3.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Dept of Cancer Immunology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028194

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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