UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013289 |
|---|---|
| Receipt number | R000015427 |
| Scientific Title | A Phase I Study of the WT1 peptide vaccine for the post-transplant AML at 2nd remission |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/02/26 19:22:25 |
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Basic information
Public title
A Phase I Study of the WT1 peptide vaccine for the post-transplant AML at 2nd remission
Acronym
A Phase I Study of the WT1 peptide vaccine for the post-transplant AM Lat 2nd remission
Scientific Title
A Phase I Study of the WT1 peptide vaccine for the post-transplant AML at 2nd remission
Scientific Title:Acronym
A Phase I Study of the WT1 peptide vaccine for the post-transplant AM Lat 2nd remission
Region
| Japan |
Condition
Condition
Acute myeloid leukemia 2nd remission(post allogeneic stem cell transplantation)
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety
Basic objectives2
Others
Basic objectives -Others
We analyze the immune monitoring of WT1 vaccination for the AML patients who underwent the stem cell transplantation at 2nd remission.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Primary endpoint is immune monitoring.
Key secondary outcomes
Secondary endpoint is 2 yerar relapse rate.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Phase1 trial 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
| 0 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients less than 20 years old.
2.Patients who achieved 2nd remission after 1st relapse
3.Patients who underwent stem cell transplantation(SCT).
4.WT1 mRNA copy number of tumor cells is more than 1000 copies / microgRNA or more than 50 copies / microgRNA
5.The ECOG performance status is a 0-3.
Key exclusion criteria
1.Patients with Down syndrome
2.Patients who relapsed less than 6 months after the end of initial therapy
3.Patients who suffered from uncontrollable infection and organ failure
4.Patients who suffered from active GVHD
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takako Miyamura |
Organization
Osaka University Graduate school of medicine
Division name
pediatricis
Zip code
Address
2-2, Yamada-Oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3932
miyamu@ped.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Miyamura,Yoshiko Hashii |
Organization
Osaka University Graduate school of medicine
Division name
pediatricis
Zip code
Address
2-2, Yamada-Oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3932
Homepage URL
miyamu@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate school of medicine, Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid from the Ministry of Education, Science and Culture of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nagoya Medical Center, Clinical Research Center
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
大阪大学大学院医学系研究科小児科
名古屋医療センター小児科
聖路加国際病院小児科
埼玉県立小児医療センター血液腫瘍科
京都大学医学部小児科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | 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 | 26 | Day |
Last modified on
| 2014 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015427
