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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025368
Receipt No. R000029207
Scientific Title A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia
Date of disclosure of the study information 2016/12/22
Last modified on 2019/01/04

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Basic information
Public title A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia
Acronym A postmarketing all-case surveillance of mogamulizumab
Scientific Title A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia
Scientific Title:Acronym A postmarketing all-case surveillance of mogamulizumab
Region
Japan

Condition
Condition CCR4-positive relapsed or refractory adult T cell leukemia-lymphoma
Classification by specialty
Hematology and clinical oncology
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 Phase IV

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, and tumor lysis syndrome)
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 All patients who were treated with mogamuliumab, including mogamulizumab-retreated patients
Key exclusion criteria None
Target sample size 300

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kaname Hasegawa
Organization Kyowa Hakko Kirin Co., Ltd.
Division name Pharmacovigilance and Quality Assurance Division, Pharmacovigilance Department
Zip code
Address 1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL 03-5205-7200
Email kaname.hasegawa@kyowa-kirin.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Manabu Iwabuchi
Organization Kyowa Hakko Kirin Co., Ltd.
Division name Pharmacovigilance and Quality Assurance Division, Pharmacovigilance Department
Zip code
Address 1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL 03-5205-7200
Homepage URL
Email manabu.iwabuchi@kyowa-kirin.co.jp

Sponsor
Institute Kyowa Hakko Kirin Co., Ltd.
Institute
Department

Funding Source
Organization Kyowa Hakko Kirin Co., Ltd.
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
Address
Tel
Email

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
2016 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://rd.springer.com/article/10.1007/s12185-017-2270-9
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 04 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 29 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 02 Month 23 Day
Date trial data considered complete
2018 Year 03 Month 29 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information Surveillance following all-case surveillance method

Management information
Registered date
2016 Year 12 Month 22 Day
Last modified on
2019 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029207

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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