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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011423
Receipt No. R000013373
Scientific Title Phase I study of a therapeutic vaccine in ATL patients with autologous dendritic cells pulsed with Tax peptides
Date of disclosure of the study information 2013/08/08
Last modified on 2019/03/10

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Basic information
Public title Phase I study of a therapeutic vaccine in ATL patients with autologous dendritic cells pulsed with Tax peptides
Acronym Phase I study of Tax specific DC vaccine for ATL patients
Scientific Title Phase I study of a therapeutic vaccine in ATL patients with autologous dendritic cells pulsed with Tax peptides
Scientific Title:Acronym Phase I study of Tax specific DC vaccine for ATL patients
Region
Japan

Condition
Condition Adult T cell leukemia/lymphoma
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of Tax-targeting dendritic cell vaccine for ATL
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety of administrating dose of Tax specific dendritic cells
Key secondary outcomes 1) Feasibility of DC preparation
2) Tax specific CTL response
3) Anti viral (HTLV-1) effect
4) Anti leukemia/lymphoma effect

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 Autologous Tax peptide pulsed dendritic cells
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)Pre-treated ATL patients in stable disease for at least one month (exclude 1st CR)
2)positive for any of HLA-A*0201, *2402, or *1101
3)No previous therapy has been performed within 4 weeks before vaccination
4)ECOG performance status 0 or 1
5) Meet the following criteria for apheresis
Hb >= 8.0 g/dL
platelet count >= 100,000/mm3,
<= 600,000/mm3
systolic blood pressure >= 90 mmHg
6) Meet the following criteria for organ function
serum-Cr < 2.0 mg/dL.
AST, ALT < 3 X ULN value,
7)Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis
8)Positive for complete type of HTLV-1 Tax which consists of intact amino acids arrangement in the epitope region
9)Negative for HLA-A*0201/Tax 11-19, HLA-A*2402/Tax301-309,HLA-A*1101/ Tax88-96 tetramer CD8+T cells, or impaired function of Tax tetramer CD8+T cells
10)Written informed consent obtained
Key exclusion criteria 1) Patients with severe complications: cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, hematological disorders, autoimmune diseases, sever allergy and severe infectious disease.
2) Patients who should receive systemic administration of steroid or immunosuppressive agents.
3) Presence of active brain metastases
4) Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant
5) Severe psychiatric disorder
6) History of HAM/TSP
7) Active multiple cancers
8) Inappropriate for study entry judged by an attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Youko Suehiro
Organization National Hospital Organization Kyushu Cancer Center
Division name Hematology
Zip code
Address 3-1-1 Notame, Minami-ku, Fukuoka, Japan
TEL 092-541-3231
Email suehiro.y@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Youko Suehiro
Organization National Hospital Organization Kyushu Cancer Center
Division name Hematology
Zip code
Address 3-1-1 Notame, Minami-ku, Fukuoka, Japan
TEL 092-541-3231
Homepage URL
Email suehiro.y@nk-cc.go.jp

Sponsor
Institute National Hospital Organization Kyushu Cancer Center
Institute
Department

Funding Source
Organization National Hospital Organization Kyushu Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 九州大学病院血液腫瘍内科(福岡県) 
Department of Hematology and Oncology, Kyushu University, Fukuoka
東京医科歯科大学病院血液内科(東京都)
Department of Hematology, Tokyo Medical and Dental University, Tokyo
九州がんセンター血液内科(福岡県)
Division of Hematology, National Kyushu Cancer Center, Fukuoka


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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25612920
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 Terminated
Date of protocol fixation
2012 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 15 Day
Last follow-up date
2015 Year 05 Month 31 Day
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013373

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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