UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026023
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email vaccine@kochi-u.ac.jp

Sponsor
Institute Department of Hematology and respiratory Medicine, School of Medicine, Kochi University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008125

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.