UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020793