UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053792 |
|---|---|
| Receipt number | R000061381 |
| Scientific Title | Integrated analysis of the past mogamulizumab clinical trials for patients with ATL, PTCL and CTCL |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/06 11:35:36 |
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Basic information
Public title
Integrated analysis of the past mogamulizumab clinical trials
Acronym
Integrated analysis of the past mogamulizumab clinical trials
Scientific Title
Integrated analysis of the past mogamulizumab clinical trials for patients with ATL, PTCL and CTCL
Scientific Title:Acronym
Integrated analysis of the past mogamulizumab clinical trials for patients with ATL, PTCL and CTCL
Region
| Japan | North America | South America |
| Europe |
Condition
Condition
CCR4-positive Adult T-cell leukemia/lymphoma
CCR4-positive Peripheral T-cell lymphoma
Cutaneous T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate an association of blood parameters and efficacy/safety of mogamulizumab treatments
Basic objectives2
Others
Basic objectives -Others
Comparing a change of blood parameters between responders and non-responders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood parameter changes
Key secondary outcomes
Plasma concentration changes of mogamulizumab
Generalized models of blood parameters
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whose data was recorded participating the following clinical trials:
Phase 2 trial investigating mogamulizumab efficacy and safety for relapsed ATL patients
Phase 2 trial comparing mogamulizumab efficacy and safety with investigator's choice for relapsed/refractory ATL patients
Phase 2 clinical trial comparing efficacy and safety of mLSG15+mogamulizumab combination therapy with mLSG15 alone for untreated ATL patients
Phase 2 trial investigating mogamulizumab efficacy and safety for relapsed PTCL patients
Phase 2 trial investigating mogamulizumab efficacy and safety for relapsed/refractory PTCL patients
Phase 1/2 trial investigating mogamulizumab efficacy and safety for relapsed/refractory CTCL patients
Phase 3 trial comparing mogamulizumab efficacy and safety with vorinostat for relapsed/refractory CTCL patients
Key exclusion criteria
Patients participated the below trials but did not take mogamulizumab administration.
Phase 2 trial comparing mogamulizumab efficacy and safety with investigator's choice for relapsed/refractory ATL patients
Phase 3 trial comparing mogamulizumab efficacy and safety with vorinostat for relapsed/refractory CTCL patients
Target sample size
625
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nishio |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
ma.oncology_2g.sd@kyowakirin.com
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Nishio |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
ma.oncology_2g.sd@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo 100-0004, JAPAN
Tel
03-5205-7200
researchethics.fj@kyowakirin.com
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will use the data from clinical trials conducted by Kyowa Kirin Co., Ltd.
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061381
| Research Plan | |
|---|---|
| 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 |
