UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013262 |
|---|---|
| Receipt number | 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 17:40:28 |
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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
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
areken@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015470
