UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026023 |
|---|---|
| Receipt number | R000008125 |
| Scientific Title | A phase I/II study of a WT1-W10 immunotherapy against high-risk MDS and MDS overt AML. |
| Date of disclosure of the study information | 2017/02/07 |
| Last modified on | 2018/02/08 09:16:02 |
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Basic information
Public title
A phase I/II study of a WT1-W10 immunotherapy against high-risk MDS and MDS overt AML.
Acronym
A phase I/II study of a WT1-W10 immunotherapy against high-risk MDS and MDS overt AML.
Scientific Title
A phase I/II study of a WT1-W10 immunotherapy against high-risk MDS and MDS overt AML.
Scientific Title:Acronym
A phase I/II study of a WT1-W10 immunotherapy against high-risk MDS and MDS overt AML.
Region
| Japan |
Condition
Condition
High-risk MDS and MDS overt AML
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to examine the safety and efficacy of an immunotherapy using WT1-W10 peptide and pertussis whole cell-vaccine. The target diseases are MDS and MDS overt AML. W10 peptide is presented by HLA-A*24:02, A*02:01, A*02:06, A*02:07, thus the patients bearing one or two of these alleles are eligible to the study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I : adverse events of grade 3 or higher, all adverse events by the CTCAE criteria
Phase II : progression free survival
Key secondary outcomes
Recurrence rate, survival rate, overall survival, maximal response, specific immune responses
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 | Vaccine |
Interventions/Control_1
3.0mg of WT1 peptide and adjuvant agent well be administrated intradermally. The administration interval is essentially every week.
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) patients diagnosed as MDS by the WHO criteria. Among them the high-risk and very high risk groups by the WHO prognosis scoring system are recruited.
2) patients who have been informed of the disease
3) patients who have no option to standard therapies or those who chose this trial over the standard therapy. Patients are not eligible to this trial if treated with the previous therapy within 4 weeks.
4) patients bearing at least one of HLA-A*24:02, A*02:01, A*02:06, A*02:07 genes.
5) Overexpression of WT1 gene was observed by real-time PCR at least once in the bone marrow or peripheral blood.
normal threshold of the WT1 transcripts:
in bone marrow or peripheral blood: =< 250 copy/ug RNA
Alternatively, over-expression of WT1 protein is confirmed by flow cytometry.
6) The presence of residual tumors in the bone marrow or peripheral blood are confirmed by one of the clinical tests listed below.
The presence of leukemic blasts
Overexpression of the WT1 transcript
The presence of canonical chromosomal abnormalities have been confirmed by chromosome examination, FISH or analysis of chimeric transcripts.
7) At least 8 days have passed after the administration of either hematopoietic factors, transfusion of platelets or RBC.
blasts in the bone marrow and peripheral blood < 50%,
neutrophil >= 500 /ul
platelet >= 20,000 /ul
Hb >= 6.5 g/dl
8) No involvement of the central nervous system or under control
9) 20 years of age or older, and less than 85 years
10) The performance status should be between 0-1 by the ECOG criteria
11) Functions of the major organs are preserved.
12) No serious complications, No double tumors including hematopoietic malignancy.
13) Written consent have been obtained from patients.
Key exclusion criteria
1)patients with infectious diseases including active Tuberculosis which are poorly controlled.
2)patients with serious comorbidities (generally those with grade 3 or higher by the NCI-CTC criteria ver 3.0)
3)pregnant women, Breast feeding mothers
4)patients with severe mental problems.
5)patients who have already been recruited in other clinical trials.
6) Patients who have dropped out after starting this clinical trials.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Yokoyama |
Organization
Kochi University, School of Medicine
Division name
Department of Hematology and respiratory Medicine
Zip code
Address
Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL
088-866-5811
vaccine@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Udaka |
Organization
School of Medicine, Kochi University
Division name
Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Zip code
Address
Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
TEL
088-880-2318
Homepage URL
vaccine@kochi-u.ac.jp
Sponsor or person
Institute
Department of Hematology and respiratory Medicine, School of Medicine, Kochi University
Institute
Department
Personal name
Funding Source
Organization
NEC Corporation
Organization
Division
Category of Funding Organization
Profit 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
| 2017 | Year | 02 | Month | 07 | 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
| 2009 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 30 | 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
| 2017 | Year | 02 | Month | 07 | Day |
Last modified on
| 2018 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008125
