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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017937
Receipt No. R000020793
Scientific Title WT1 peptide vaccination for patinets with hematological CR after induction chemotherapy
Date of disclosure of the study information 2015/06/17
Last modified on 2020/01/20

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Basic information
Public title WT1 peptide vaccination for patinets with hematological CR after induction chemotherapy
Acronym WT1 peptide vaccination for patinets with hematological CR after induction chemotherapy
Scientific Title WT1 peptide vaccination for patinets with hematological CR after induction chemotherapy
Scientific Title:Acronym WT1 peptide vaccination for patinets with hematological CR after induction chemotherapy
Region
Japan

Condition
Condition Cancer vaccine
Classification by specialty
Clinical immunology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety of vaccination between induction chemotyerapy and conslidation chemotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes Safety of WT1 vaccine therapy before consloidation chemothrapy
Key secondary outcomes 2 year DFS or OS

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 WT1 peptide + WT1 helper peptide with Montanide
Interventions/Control_2 WT1 peptide + WT1 helper peptide + CpG with Montanide
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 1. Hematological CR aftet induction chemotherapy
2. HLA0201 or 2402
3. PS0-1 and main organs are good status
4. Recovery of hematopoiesis
Key exclusion criteria 1. double cancer
2. active infections
3. autoinflamatory disease
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Haruo
Middle name
Last name Sugiyama
Organization Osaka university
Division name Cancer immunotherapy
Zip code 5650871
Address 2-15 Yamadaoka in Suita city
TEL +81-6-6879-3676
Email clinical-trial@cit.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Haruo
Middle name
Last name Sugiyama
Organization Osaka university
Division name Cancer immunotherapy
Zip code 5650871
Address 2-15 Yamadaoka in Suita city
TEL +81-6-6879-3676
Homepage URL
Email clinical-trial@cit.med.osaka-u.ac.jp

Sponsor
Institute Cancer immunotherapy of Osaka University
Institute
Department

Funding Source
Organization The Ministry of Health Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Cancer immunotherapy, Osaka University
Address 2-2 Yamadaoka, Suita City
Tel 0668793676
Email mogura@sahs.med.osaka-u.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
2015 Year 06 Month 17 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
2015 Year 05 Month 15 Day
Date of IRB
2015 Year 05 Month 15 Day
Anticipated trial start date
2015 Year 05 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 17 Day
Last modified on
2020 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020793

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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