UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015997 |
|---|---|
| Receipt number | R000018592 |
| Scientific Title | WT1 peptide-based cancer vaccine for long-term maintenance of anti-tumor immunity |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2024/03/11 19:06:40 |
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Basic information
Public title
WT1 peptide-based cancer vaccine for long-term maintenance of anti-tumor immunity
Acronym
WT1 vaccine for long-term anti-tumor immunity
Scientific Title
WT1 peptide-based cancer vaccine for long-term maintenance of anti-tumor immunity
Scientific Title:Acronym
WT1 vaccine for long-term anti-tumor immunity
Region
| Japan |
Condition
Condition
solid tumor, malignant lymphoma, acute leukemia
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
| Gastrointestinal surgery | Chest surgery | Breast surgery |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate WT1-specific immune responses as a primary objective induced by WT1 peptide vaccine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
DTH to WT1 peptide
Frequency of WT1 specific CTLs
Key secondary outcomes
Safety
1 Numbers and frequencies of adverse effects defined in NCI-CTCAE v4.0
2 Frequencies of hematological- and non-hematological adverse effects which result in suspension or withdrawal of WT1 peptide vaccine
Anti-tumor effects
Anti-tumor effects are evaluated at 3-6 months intervals by the method described elsewhere.
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
Administration of 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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. diagnosed as having malignant tumor and treated with WT1 peptide vaccine in the following clinical trials in Osaka University Hospital
WT1 peptide vaccine for solid tumor
WT1 peptide vaccine for malignant lymphoma
WT1 peptide vaccine for hematologic malignancies after allogeneic stem cell transplantation phase I
Dose-increasing WT1 peptide vaccine for MDS phase I
2. Clinical usefulness of WT1 peptide vaccine was observed and its usefulness was accepted by a board
3.
Neutrophyl >= 1,000/ul no use of hematopoietic factors within 14days
SpO2>=94 percent (room air)
Plt>=50,000/ul no transfusion of platelet within 14days
Hb>=8g/dl no transfusion of RBC within 14 days
serm Crn <= 2.0mg/dL
serum T.Bil<=2.0 mg/dl
serum AST ALT <= 120U/L
4. Age: 20<=, <=85.
5.ECOG Performance Status (PS) 0-1
6. Written informed consent was obtained.
Key exclusion criteria
1. having severe infectious disease
2. having developed adverse effects (grade >=4) in the prior WT1 peptide vaccine trial
3. having severe complications
4. having severe mental disorders
Target sample size
56
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
Dept Functional Diagnostic Science
Zip code
Address
1-7 Yamada-oka Suita city Osaka, Japan
TEL
06-6879-2597
sugiyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Oji |
Organization
Osaka University Graduate School of Medicine
Division name
Cancer Stem Cell Biology
Zip code
Address
1-7 Yamada-oka Suita city Osaka, Japan
TEL
06-6879-2597
Homepage URL
http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/index.htm
oji@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate Shool of Medicine,
Functional Diagnostic Science
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Non-pharmaceutical companies
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
| 2014 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018592
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