UMIN-CTR Clinical Trial

Basic information
Public title	Phase II clinical trials of WT1 vaccine for post hematopoietic stem cell transplant patients
Acronym	Phase II clinical trials of WT1 vaccine for post hematopoietic stem cell transplant patients
Scientific Title	Phase II clinical trials of WT1 vaccine for post hematopoietic stem cell transplant patients
Scientific Title:Acronym	Phase II clinical trials of WT1 vaccine for post hematopoietic stem cell transplant patients
Region	Japan

Condition
Condition	Acute leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine whether relapse decreased after HSCT by administration of WT1 vaccine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	2year OS PFS
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	Vaccine
Interventions/Control_1	WT1 peptide vaccine
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	AML or ALL post HSCt high risk for relapse (HSCT in non-CR, 2nd HSCT for relapse)
Key exclusion criteria	Double cancer Infectious disease Heart failure
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Naoki Middle name Last name Hosen
Organization	Osaka University
Division name	Medicine
Zip code	565-0871
Address	1-7 Yamada-Oka, Suita
TEL	0668793676
Email	hnaoki@imed3.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Naoki Middle name Last name Hosen
Organization	Osaka University Graduate School of Medicine
Division name	Medicine
Zip code	565-0871
Address	2-2, Yamada-Oka, Suita, Osaka, Japan
TEL	0668793676
Homepage URL
Email	hnaoki@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Kaken
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University
Address	2-15, Yamadaoka, Suita, Osaka
Tel	+81668793835
Email	hnaoki@imed3.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	2013 Year 09 Month 19 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	2011 Year 12 Month 15 Day
Date of IRB	2011 Year 12 Month 15 Day
Anticipated trial start date	2012 Year 01 Month 10 Day
Last follow-up date	2016 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 17 Day
Last modified on	2019 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013164