UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of a therapeutic vaccine in ATL patients with autologous dendritic cells pulsed with Tax peptides
Title of the study (Brief title)	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	Youko Suehiro
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Hematology
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	Youko Suehiro
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Hematology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 07 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/25612920
Results
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