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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031960
Receipt No. 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 2018/06/09

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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
Email 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/
Email oji@sahs.med.osaka-u.ac.jp

Sponsor
Institute Osaka university Graduate School of Medicine
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 22 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
2018 Year 03 Month 29 Day
Last modified on
2018 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036496

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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