UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Novel autologous dendritic cell vaccine therapy targeting HTLV-1 specific antigen Combined with anti-CCR4 antibody for previously treated patients with adult T-cell leukemia. A phase Ia/Ib study.
Title of the study (Brief title)	Phase Ia/Ib study of Tax-targeting DC vaccine combined with anti-CCR4 Ab for ATL
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 and tolerability of Tax-targeting DC vaccine combined with anti-CCR4 antibody for ATL
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Safety and tolerability of Tax-targeting DC vaccine combined with anti-CCR4 antibody
Key secondary outcomes	1) anti-ATL effect 2) progression- free survival 3) time to new treatment (TTNT) 4) tumor marker (sIL-2R) 5) HTLV-1 proviral load 6) CD4+CD25+Foxp3+ cells 7) level of Mogamulizumab 8) anti-ATL effect and adverse event in the follow up period

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	Tax-targeting DC vaccine KW-0761 (Mogamulizumab)
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 who obtain more than SD by previous treatment 2) positive for any of HLA-A*0201, *2402, or *1101 3) No previous therapy has been performed within 4 weeks before vaccination; without the exacerbation 4) ECOG performance status 0 or 1 5) Meet the following criteria for organ function serum-Cr < 2.0 mg/dL. AST, ALT < 3 X ULN value, 6) Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis 7) 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) Non-hematological adverse event Grade 3 or more due to KW-0761 before the trial are not recover 4) After allogeneic hematopoietic stem cell transplantation, or allograft is planned 5) Presence of active central nerve lesion 6) Pregnant, lactating, or possibly pregnant women, or willing to be pregnant Severe psychiatric disorder 7) Complication with psychosis or psychotic symptoms 8) History of HAM/TSP 9) Active multiple cancers 10) Inappropriate for study entry judged by an attending physician
Target sample size	9

Research contact person
Name of lead principal investigator	Youko Suehiro
Organization	National Hospital Organization Kyushu Cancer Center
Division name	Cell Therapy/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	Cell Therapy/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	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	National Hospital Organization Kyushu Cancer Center
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	九州がんセンター（福岡県） National Kyushu Cancer Center, Fukuoka 九州大学病院（福岡県）　 Kyushu University, Fukuoka 東京医科歯科大学病院（東京都） Tokyo Medical And Dental University, Tokyo

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 13 Day
Last follow-up date	2018 Year 06 Month 06 Day
Date of closure to data entry	2018 Year 07 Month 02 Day
Date trial data considered complete	2018 Year 08 Month 17 Day
Date analysis concluded	2018 Year 11 Month 30 Day

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

Management information
Registered date	2015 Year 03 Month 02 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=R000019348