UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048043 |
|---|---|
| Receipt number | R000054739 |
| Scientific Title | The specified drug use result surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory peripheral T-cell lymphoma and relapsed or refractory cutaneous T-cell lymphoma |
| Date of disclosure of the study information | 2022/06/13 |
| Last modified on | 2022/06/13 15:10:57 |
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Basic information
Public title
The specified drug use result surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory peripheral T-cell lymphoma, and relapsed or refractory cutaneous T-cell lymphoma
Acronym
The specified drug use result surveillance of mogamulizumab
Scientific Title
The specified drug use result surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory peripheral T-cell lymphoma and relapsed or refractory cutaneous T-cell lymphoma
Scientific Title:Acronym
The specified drug use result surveillance of mogamulizumab
Region
| Japan |
Condition
Condition
CCR4 positive relapsed or refractory peripheral T-cell lymphoma, and relapsed or refractory cutaneous T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of mogamulizumab in daily practice by
(1)detecting unknown adverse drug reactions (ADRs)
(2)understanding the occurrence status of ADRs
(3)capturing factors that are likely to affect safety and efficacy
(4)assessing priority survey items and other relevant matters.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Safety
(1)Occurrence of ADRs (e.g., types and incidence)
(2)Evaluation on factors likely to affect safety
(3)Occurrence of serious adverse events
(4)Occurrence of priority survey items (infusion-related reactions, skin disorders, infections and immune disorders associated with hematological toxicity, tumor lysis syndrome, and interstitial lung disease)
2.Efficacy
(1)Response rate (by attending physician)
(2)Survival rate at 31 weeks after treatment initiation
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have CCR4 positive relapsed or refractory peripheral T-cell lymphoma, and relapsed or refractory cutaneous T-cell lymphoma, and were treated with mogamulizumab
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takashima |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
100-0004
Address
1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
akira.takashima.jc@kyowakirin.com
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Tsuji |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
100-0004
Address
1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL
070-3143-7893
Homepage URL
yukie.tsuji.dq@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Pharmacovigilance Department
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Pharmacovigilance Department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2022 | Year | 06 | Month | 13 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
142
Results
N/A
Results date posted
| 2022 | Year | 06 | Month | 13 | Day |
Results Delayed
Results Delay Reason
N/A
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
N/A
IPD sharing Plan description
N/A
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 03 | Day |
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054739
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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