UMIN-CTR Clinical Trial

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
Name of lead principal investigator	1st name Kouichi Middle name Last name Kawamura
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
Email	kouichi.kawamura.1r@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	03-5205-7200
Homepage URL
Email	yukie.tsuji.dq@kyowakirin.com

Sponsor
Institute	Kyowa Kirin Co., Ltd.
Institute
Department

Funding Source
Organization	Kyowa 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	N/A
Address	N/A
Tel	N/A
Email	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	2016 Year 12 Month 22 Day

Related information
URL releasing protocol	N/A
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.111
Number of participants that the trial has enrolled	597
Results	In the safety analysis population, adverse drug reactions (ADRs) were reported in 73.4% (38.6% serious cases) of patients. The most common ADRs were skin disorders (33.2% [10.8% serious cases]), infusion-related reactions (30.1% [4.7% serious cases]), and infections (22.0% [14.7% serious cases]). In the effectiveness analysis population, the best overall response rate and the response rate at the end of therapy were 57.9% and 42.0%, respectively. The median overall survival was 5.5 months.
Results date posted	2020 Year 12 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The majority of patients (93.8%) were of acute or lymphoma subtype, and in 30.8% of patients, mogamulizumab was used in combination with other modalities, mainly cytotoxic agents. The median age of patients was 67.0 years, with patients aged over 70 years accounting for 41.6% of the population. Following mogamulizumab treatment, 49 patients (8.6%) underwent allogeneic HSCT, of which 47 were aged under 70 years. The median interval between the last mogamulizumab treatment and the HSCT was 36 days (range 6-191 days). In the safety analysis population, the mean number of mogamulizumab administrations was 5.4, and 60% of patients did not complete all eight courses of mogamulizumab therapy, mainly due to disease progression (52.5%) and adverse events (37.0%).
Participant flow	Data were collected from all patients for whom mogamulizumab treatment was initiated from the launch on May 29, 2012 to before May 1, 2013, as daily clinical practice, and who had planned to be received intravenous infusions of mogamulizumab 1.0 mg/kg once weekly for 8 weeks, the approved dosing schedule in Japan, alone or in combination with other modalities. Patients were observed for 24 weeks after the last dose of mogamulizumab.
Adverse events	In the safety analysis population, 73.4% and 38.6% of patients were reported to experience at least one ADR and serious ADR, respectively. Of the 572 patients, ADRs in 42 patients (7.3%) resulted in death that was attributable to mostly infections (3.1% [18/572]) and graft vs host disease (GVHD; 1.2% [7/572]). The most common ADRs were skin disorders (33.2%), IRRs (30.1%), and infections (22.0%), of which infections (14.7%) and skin disorders (10.8%) were the most common serious ADRs.
Outcome measures	The surveillance had five priority survey items for adverse events and adverse drug reactions (ADRs)-infusion-related reactions, skin disorders, infections, immune system disorders, and tumor lysis syndrome, which were determined as items to be collected intensively regardless of presence or absence of events, based on safety information from clinical studies. The best overall response during mogamulizumab therapy and response at the end of mogamulizumab therapy were assessed by the attending physician according to the response criteria used in the phase 2 study in patients with relapsed ATL in Japan.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 25 Day
Date of IRB	2012 Year 04 Month 23 Day
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	2020 Year 06 Month 10 Day

Other
Other related information	Surveillance following all-case surveillance method

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://center6.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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