UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008696 |
|---|---|
| Receipt number | R000010214 |
| Scientific Title | Monitoring of the immune responses following mogamulizumab containing treatment in patients with adult T-cell leukemia-lymphoma (MIMOGA study) |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2022/08/22 09:32:27 |
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Basic information
Public title
Monitoring of the immune responses following mogamulizumab containing treatment in patients with adult T-cell leukemia-lymphoma (MIMOGA study)
Acronym
Monitoring of the immune responses following mogamulizumab
Scientific Title
Monitoring of the immune responses following mogamulizumab containing treatment in patients with adult T-cell leukemia-lymphoma (MIMOGA study)
Scientific Title:Acronym
Monitoring of the immune responses following mogamulizumab
Region
| Japan |
Condition
Condition
Adult T-cell leukemia-lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to clarify the mogamulizumab induced effect on human immune system of ATL patients by measuring the number of CD4/CD8 positive T cells, NK cells, B cells, Treg cells, HTLV-1 or CMV specific cytotoxic T cells, HTLV-1 virus load, and concentrations of many kind of cytokines in the blood, during and after mogamulizumab containing treatment. The relationships between these immunological parameters and clinical efficacies of mogamulizumab or mogamulizumab related adverse events are also investigated. The ultimate goal of the present study is to establish the most effective and safety usage of mogamulizumab in ATL patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the immune responses such as the number of CD4/CD8 positive T cells, NK cells, B cells, Treg cells, and HTLV-1 specific cytotoxic T cells in blood following mogamulizumab containing treatment in the ATL patients.
Key secondary outcomes
Efficacy of mogamulizumab containing treatment
Adverse events of mogamulizumab containing treatment
Overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are diagnosed as adult T-cell leukemia-lymphoma and are scheduled for administration of mogamulizumab.
2) Subjects who are 20 years or older.
3) Subjects who have given written voluntary informed consent to participate in the present study
4) Subjects who have a result of HLA-A typing (A physician can make a decision of test item regarding immune monitoring)
Key exclusion criteria
1) Subjects with a history of receiving mogamulizumab
2) Subjects with a history of receiving allogeneic hematopoietic stem cell transplantation.
3) Subjects who are determined to have any serious difficulties for 6 months immune monitoring after their enrollment by the physician.
4) Subjects who are pregnant, of childbearing potential, or lactating.
5) Subjects who are determined to be unsuitable for enrolled in the present study by the physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Immunology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2135
itakashi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Kusumoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Hematology and Oncology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8738
Homepage URL
kusshan@rb3.so-net.ne.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
SRL Medisearch Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Hospital Clinical Trial Management Center
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
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
公益財団法人慈愛会 今村病院分院（鹿児島県）
国立病院機構 九州がんセンター（福岡県）
大分県立病院（大分県）
日本赤十字社長崎原爆病院（長崎県）
佐世保市立総合病院（長崎県）
国立病院機構 熊本医療センター（熊本県）
熊本大学医学部附属病院（熊本県）
大分大学医学部附属病院（大分県）
長崎大学大学院医歯薬学総合研究科 原研内科(長崎県)
福岡大学 腫瘍・血液・感染症内科（福岡県）
鹿児島大学病院（鹿児島県）
名古屋市立大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 20 | 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
| 2012 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 07 | Month | 31 | Day |
Other
Other related information
Multicenter prospective observational study
Ancillary study by using preserved specimens to determine biomarkers to predict efficacy and safety of mogamulizumab containing treatment
1) Comprehensive genetic testing including genome-wide association study: GWAS study
2) Serum multiplex cytokine analysis
3) Comprehensive serum protein array
Management information
Registered date
| 2012 | Year | 08 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010214
