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 UMIN000011519
Receipt No. R000012910
Scientific Title WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome
Date of disclosure of the study information 2013/08/19
Last modified on 2018/12/18

* 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 WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome
Acronym siTCR-WT1-AML/MDS gene therapy
Scientific Title WT1-antigen specific TCR-gene transduced T lymphocytes transfer using MS3-WT1-siTCR vector for acute myelogeneous leukemia and myelodysplastic syndrome
Scientific Title:Acronym siTCR-WT1-AML/MDS gene therapy
Region
Japan

Condition
Condition acute myelogenous leukemia, myelodysplastic syndrome
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety of WT1-TCR gene transduced cell transfer and WT1 peptide vaccine
Basic objectives2 Others
Basic objectives -Others # Cell kinetics of TCR-gene transducsed cells in peripheral blood
# Hematological effect, including molecular levels using PCR methods
# Immunological analysis
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes # Occurence of adverse events
# Changes of laboratory data
# RCR(replication competent retrovirus) excretion
# Clonal changes of TCR-gene transduced T lymphocytes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 # WT1-TCR gene transduced lymphocyte transfer
two doses of 2x10*8 cells (day0, day28)
# WT1 peptide vaccination
two SQ injections of 300mcg each (day 30, day44)
Interventions/Control_2 # WT1-TCR gene transduced lymphocyte transfer
two doses of 1x10*9 cells (day0, day28)
# WT1 peptide vaccination
two SQ injections of 300mcg each (day 30, day44)
Interventions/Control_3 # WT1-TCR gene transduced lymphocyte transfer
two doses of 5x10*9 cells (day0, day28)
# WT1 peptide vaccination
two SQ injections of 300mcg each (day 30, day44)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient diagnosed as either of the followings;
a) acute myelogenous leukemia, relapsed or resistent to primary therapy, including atypical leukemia and transformed from myelodysplastic syndrome
b) therapy-resistent myelodysplastic syndrome, not indicated for hematopoietic stem cell transplant
2. HLA-A*24:02-positive
3. PCR-confirmed WT1-antigen expression on leukemic or MDS cells
4. Performance status(ECOG) 0 to 2
5. Aged 20 years or more
6. Full recovery after the previous therapy
7. Normal major organ function, and meeting the criteria below
# Serum total bilirubin within three times of upper normal level
# AST(GOT)/ALT(GPT) within three times of upper normal level
# Serum creatinine within three times of upper normal level
# left ventricular ejection fraction of 55% or more
# Arterial oxygen saturation of 94% or more
8. Having written informed consent
Key exclusion criteria 1.Having the following serious complications
# Uncontrolled anigina pectoris, myocardial infarction, or heart failure
# Uncontrolled diabetes mellitus or hytertention
# Uncontrolled infection
# X-ray-proven interstitial pneumonia or pulmonary fibrosis
# Autoimmune disease
2. History of severe allergy
3. Either of HBV, HCV, HIV and HTLV-1 infection
4. Expected life splan of 4 months or less
5. Uncontrolled pleural effusion, ascites or pericardial effusion
6. CNS involvement affecting safety issues
7. Systemic corticostoroid (prednisolone of 0.5mg/kg/day or more), or immuno-suppressive therapy
8. Mental illness or drug dependency affecting informed consent
9. Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm
10. Lasting less than four months from the previous enrollment to clinical trials
11. Received allogeneic hematopoietic stem cell transplantation
12. Inappropriate for study entry judged by an attending physician
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Shiku
Organization Mie University Graduate School of Medicine
Division name Department of Immuno-Gene Therapy
Zip code
Address 2-174, Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5187
Email shiku@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kageyama
Organization Mie University Graduate School of Medicine
Division name Department of Immuno-Gene Therapy
Zip code
Address 2-174, Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-231-5187
Homepage URL http://www.shikuken.jp/
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University, Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
Institute
Department

Funding Source
Organization Mie University,Ehime University, Fujita Health University, Nagoya University(MEXT, Japan), and Takara Bio Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Ehime University, Fujita Health University, Nagoya University, Takara Bio Inc.
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 三重大学医学部附属病院(三重県)、愛媛大学医学部附属病院(愛媛県)、藤田保健衛生大学病院(愛知県)、名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.bloodjournal.org/content/130/18/1985.long?sso-checked=true
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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 19 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
2013 Year 08 Month 19 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012910

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.