UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 trial for hematological CR patients of AML after chemotherapy.
Acronym	Phase 2 trial for hematological CR patients of AML after chemotherapy.
Scientific Title	Phase 2 trial for hematological CR patients of AML after chemotherapy.
Scientific Title:Acronym	Phase 2 trial for hematological CR patients of AML after chemotherapy.
Region	Japan

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

Objectives
Narrative objectives1	Make sure the effectiveness of WT1-peptide therapy for protection against relapse for the hematological CR petients after chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1 year OS, 2 year OS 1 year DFS, 2 year DFS
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 therapy
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 patients who archive the hematological CR after chemotherapy. The main organ fucntion is OK. (AST<normal limit*4, ALT<normal limit*4, T-bil<2.0mg/dl, Cr<2.0mg/dl,ECG is OK, SpO2>94%) HLA-A is A0201 or A2402. Hematopoietic function recovers over below. (Neu>1000, Plt>50.000, Hb 7.0)
Key exclusion criteria	AML associated with MPD double cancer active infection post hematological stem cell transplantation
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Haruo Sugiyama
Organization	Osaka University
Division name	Functional Diagnostic Science
Zip code
Address	2-15 Yamadaoka in Suita city
TEL	06-6879-3676
Email	clinical-trial@cit.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Jun Nakata
Organization	Osaka University
Division name	Cancer Immunotherapy
Zip code
Address	2-15 Yamadaoka in Suita city
TEL	06-6879-3676
Homepage URL
Email	clinical-trial@cit.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Cancer Immunotyerapy of Osaka University
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
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	2014 Year 12 Month 08 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 05 Month 12 Day
Date of IRB	2011 Year 05 Month 12 Day
Anticipated trial start date	2011 Year 05 Month 12 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	2014 Year 12 Month 08 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=R000018470