UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016683 |
|---|---|
| Receipt number | R000019348 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2015/03/05 |
| Last modified on | 2019/03/10 15:01:05 |
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Basic information
Public title
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.
Acronym
Phase Ia/Ib study of Tax-targeting DC vaccine combined with anti-CCR4 Ab for ATL
Scientific Title
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.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Youko Suehiro |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Cell Therapy/Hematology
Zip code
Address
3-1-1 Notame, Minami-ku, Fukuoka, Japan
TEL
092-541-3231
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
Cell Therapy/Hematology
Zip code
Address
3-1-1 Notame, Minami-ku, Fukuoka, Japan
TEL
092-541-3231
Homepage URL
suehiro.y@nk-cc.go.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019348
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