UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004753 |
|---|---|
| Receipt number | R000005657 |
| Scientific Title | Phase I clinical trial of immunotherapy with WT1 peptide vaccine for hematological malignancies after stem cell transplantation |
| Date of disclosure of the study information | 2010/12/21 |
| Last modified on | 2014/11/27 15:47:36 |
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Basic information
Public title
Phase I clinical trial of immunotherapy with WT1 peptide vaccine for hematological malignancies after stem cell transplantation
Acronym
Phase I clinical trial of immunotherapy with WT1 peptide vaccine for hematological malignancies after stem cell transplantation
Scientific Title
Phase I clinical trial of immunotherapy with WT1 peptide vaccine for hematological malignancies after stem cell transplantation
Scientific Title:Acronym
Phase I clinical trial of immunotherapy with WT1 peptide vaccine for hematological malignancies after stem cell transplantation
Region
| Japan |
Condition
Condition
Acute myeloid or lymphoid leukemia
malignant lymphoma
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety of WT1 vaccine for patients with hematological malignancies post alloggenic stem cell transplant
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Modified WT1 peptide (235-243) with montanide ISA51 is subcutaneously injected weekly for a month.
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
see Japanese protocol or ask directly to us
Key exclusion criteria
see Japanese protocol or ask directly to us
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Sugiyama |
Organization
Osaka University Graduate School of Medicine
Division name
Functional Diagnostic Science
Zip code
Address
1-7, Yamada-Oka, Suita, Osaka
TEL
06-6879-2593
sugiyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hosen |
Organization
Osaka University
Division name
Cancer Immunmotherapy
Zip code
Address
2-2, Yamada-oka, Suita City, Osaka , Japan
TEL
06-6879-3676
Homepage URL
hnaoki@imed3.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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25186852
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
| 2010 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005657
