UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031960 |
|---|---|
| Receipt number | R000036496 |
| Scientific Title | A clinical study of WT1 peptide-based cancer vaccine WT1 Trio for myeloproliferative neoplasms |
| Date of disclosure of the study information | 2018/05/22 |
| Last modified on | 2024/03/11 18:56:02 |
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Basic information
Public title
A clinical study of WT1 peptide-based cancer vaccine WT1 Trio for myeloproliferative neoplasms
Acronym
WT1 Trio cancer vaccine for MPN
Scientific Title
A clinical study of WT1 peptide-based cancer vaccine WT1 Trio for myeloproliferative neoplasms
Scientific Title:Acronym
WT1 Trio cancer vaccine for MPN
Region
| Japan |
Condition
Condition
myeloproliferative neoplasms (Polycythemia vera, Essential thrombocythemia,Essential thrombocytosis)
MPN (PV, ET)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
WT1 peptide-based cancer vaccine WT1 Trio is administered to patients with myloproliferative neoplasms, PV and ET to study its safety as the primary endpoint. Induction of WT1-specific immune responses and its clinical efficacy are analyzed as secondary endpoints.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Induction of WT1-specific immune responses
Clinical efficacy
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
Montanide ISA-51- adjuvanted, three WT1-derived peptides (WT1-126, mWT1-235, WT1-332) are intradermally administered eight times at three-week intervals. Peptide dose was 0.5 mg each for first and second administrations, amd 1.0mg each at later administrations.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- A disease-notified patient with PV or ET according to WHO classification (2016)
- Abnormally high WT1 mRNA level has been recorded >= 100 copies and 2,000 copies /microgram RNA for PBMC and bone marrow samples, respectively.
- HLA-A 24:02 or 02:01
- 16-85 years old.
- PS: 0-2
- Neu >=1,000/ul, Plt>= 50,000/ul
- serum ALT <=120 U/L
- serum total Bil <= 2.0 mg/dL
- serum Alb >=2.5 g/dL
- serum Creatinine <= 2.0 mg/dL
- ECG: no severe abnormal findings
- SpO2 >= 94 percent
- written informed consent obtained
Key exclusion criteria
- >=10% of blasts in the peripheral blood
- active infectious disease including tuberculosis.
- active autoimmune disease and/or collagen disease
-severe complications (grade >=3 according to CTCAE v4.0)
- severe mental disorders
- participation in other clinical trial which could affect the results of the study
- having other malignant disease within three years prior to the registration
-Dicided as inadequate by the principal investigator or a subinvestigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke OJI |
Organization
Osaka university
Division name
Graduate School of Medicine, Dept. of Functional Diagnositc Science
Zip code
Address
1-7 Yamada-oka Suita, Osaka, Japan
TEL
06-6879-2597
oji@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke OJI |
Organization
Osaka university
Division name
Dept. Cancer vaccine immunotherapy
Zip code
Address
2-2 Yamada-oka Suita Osaka Japan
TEL
06-6879-3676
Homepage URL
http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/
oji@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-Funding
Organization
Division
Category of Funding Organization
Self funding
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 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 22 | 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
| 2018 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 22 | 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
| 2018 | Year | 03 | Month | 29 | 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=R000036496
