UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005319 |
|---|---|
| Receipt number | R000006321 |
| Scientific Title | Phase II clinical trial of immunotherapy with WT1 peptide vaccination for pediatric hematological malignancies after allogeneic stem cell transplantation. |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2014/02/25 10:13:02 |
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Basic information
Public title
Phase II clinical trial of immunotherapy with WT1 peptide vaccination for pediatric hematological malignancies after allogeneic stem cell transplantation.
Acronym
Phase II clinical trial of immunotherapy with WT1 peptide vaccination for pediatric hematological malignancies after allogeneic stem cell transplantation.
Scientific Title
Phase II clinical trial of immunotherapy with WT1 peptide vaccination for pediatric hematological malignancies after allogeneic stem cell transplantation.
Scientific Title:Acronym
Phase II clinical trial of immunotherapy with WT1 peptide vaccination for pediatric hematological malignancies after allogeneic stem cell transplantation.
Region
| Japan |
Condition
Condition
Acute lymphoid or myeloid leukemia, acute unclassified leukemia, malignant lymphoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the afficacy of WT1 peptide vaccine for ediatric hematological malignancies after allogeneic stem cell tranpslantaion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse free survival from the day of stem cell transplantation
Key secondary outcomes
Adverse events
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
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Modified WT1 pepitide with montanide is subcutaneously injected weekly for 3months.
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
See Japanese protocol or ask duresctly to us
Key exclusion criteria
Patients with severe complications.
Target sample size
22
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, Yamadaoka Suita
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
Division name
Pediatrics
Zip code
Address
2-2, Yamadaoka Suita
TEL
06-6879-3932
Homepage URL
areken@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | 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
| 2011 | Year | 03 | Month | 25 | Day |
Last modified on
| 2014 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006321
