UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
Title of the study (Brief title)	WT1 peptide vaccine study after "Adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
Region	Japan

Condition
Condition	Acute myelogeous lekemia, Myelodysplastic syndrome
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and the immune reaction in the peptide vaccinated patients who have completed "adoptive transfer of lymphocytes transduced with WT1-specific TCR gene"
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety Immune reaction
Key secondary outcomes

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	subcutaneous injection of WT1 peptide, 300microgram mixed with Montanide ISA-51 VG
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patient who completed "adoptive transfer of lymphocytes transduced with WT1-specific TCR gene(UMIN000011519)" 2.adverse events whith grade 1 or 2 during the above study 3.Performance status(ECOG) 0 to 1 4.Having written informed consent
Key exclusion criteria	1.Having 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 # Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL Thrombosis tendency 2.History of serious hypersensitivity 3.Unctrolled pleural effusion, ascites, or pericardial effusion 4.Uncontrolled CNS metastasis 5.Systemic corticostoroid or immuno-suppressive therapy 6. Inappropriate for WT1 peptide administration, i.e. allergic to the peptide or adjuvant 7.Mental illness or drug dependency affecting informed consent 8.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm 9. Lasting less than four weeks from the previous enrollment to clinical trials 11.Inappropriate for study entry judged by an attending physician
Target sample size	9

Research contact person
Name of lead principal investigator	Shinichi Kageyama
Organization	Mie University Graduate School of Medicine
Division name	Immuno-Gene Therapy
Address	2-174, Edobashi, Tsu, Mie 514-8507 Japan
TEL	059-231-5380
Email	kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Shinichi Kageyama
Organization	Mie University Graduate School of Medicine
Division name	Immuno-Gene Therapy
Address	2-174, Edobashi, Tsu, Mie 514-8507 Japan
TEL	059-231-5380
Homepage URL
Email	kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Mie University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 06 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 09 Month 10 Day
Anticipated trial start date	2015 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 06 Day
Last modified on	2016 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013659