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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013262
Receipt No. R000015470
Scientific Title Phase II clinical trials of WT1 vaccine for post hematopoietic stem cell transplant patients
Date of disclosure of the study information 2014/02/25
Last modified on 2015/05/21

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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 leuekmia
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this clinical trial is to clarify the safety and effectiveness of WT1 cocktail vaccine for pediatric hematological malignancy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes 2 years overall survival, safety.
Key secondary outcomes 2 years event free survival

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
Medicine Vaccine
Interventions/Control_1 WT1 peptide-based cancer vaccine will be injected intradermally in total 6 times by weekly.
After 6 times,monthly and for 2 years.
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

Not applicable
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria 1. ALL or AML
2. Achieved complete remission.
3. WTmRNA expression
4. HLA A2402 and or 0201
5. No active GVHD
6. Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
7. Informed consent from legal garadian
8. age below 20 y.o
Key exclusion criteria 1) active infectious diseases
2) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
3) Other severe problems unsuitable for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiko Hashii
Organization Osaka University Graduate School of Medicine
Division name Pediatrics
Zip code
Address 2-2, Yamada-oka, Suita City, Osaka , Japan
TEL 06-6879-3932
Email areken@ped.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiko Hashii
Organization Osaka university graduate school of medicine
Division name Pediatrics
Zip code
Address 2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL 06-6879-3932
Homepage URL
Email areken@ped.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
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 02 Month 25 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 Preinitiation
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2015 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015470

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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