UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011423 |
|---|---|
| Receipt number | 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 14:56:44 |
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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
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
suehiro.y@nk-cc.go.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013373
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
