Unique ID issued by UMIN | UMIN000025368 |
---|---|
Receipt number | 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 | 2024/06/10 17:06:44 |
A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia
A postmarketing all-case surveillance of mogamulizumab
A postmarketing all-case surveillance of mogamulizumab in patients with CCR4 positive relapsed or refractory adult T cell lymphoma-leukemia
A postmarketing all-case surveillance of mogamulizumab
Japan |
CCR4-positive relapsed or refractory adult T cell leukemia-lymphoma
Hematology and clinical oncology |
Malignancy
NO
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.
Safety,Efficacy
Phase IV
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
Observational
Not applicable |
Not applicable |
Male and Female
All patients who were treated with mogamuliumab, including mogamulizumab-retreated patients
None
300
1st name | Kouichi |
Middle name | |
Last name | Kawamura |
Kyowa Kirin Co., Ltd.
Pharmacovigilance Department
100-0004
1-9-2 Otemachi, Chiyoda-ku, Tokyo
03-5205-7200
kouichi.kawamura.1r@kyowakirin.com
1st name | Yukie |
Middle name | |
Last name | Tsuji |
Kyowa Kirin Co., Ltd.
Pharmacovigilance Department
100-0004
1-9-2 Otemachi, Chiyoda-ku, Tokyo
03-5205-7200
yukie.tsuji.dq@kyowakirin.com
Kyowa Kirin Co., Ltd.
Kyowa Kirin Co., Ltd.
Profit organization
Japan
N/A
N/A
N/A
N/A
NO
2016 | Year | 12 | Month | 22 | Day |
N/A
Published
https://onlinelibrary.wiley.com/doi/10.1111/ejh.13220
597
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.
2020 | Year | 12 | Month | 07 | Day |
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%).
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.
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.
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.
Completed
2012 | Year | 04 | Month | 25 | Day |
2012 | Year | 04 | Month | 23 | Day |
2012 | Year | 05 | Month | 29 | Day |
2014 | Year | 04 | Month | 30 | Day |
2018 | Year | 02 | Month | 23 | Day |
2018 | Year | 03 | Month | 29 | Day |
2020 | Year | 06 | Month | 10 | Day |
Surveillance following all-case surveillance method
2016 | Year | 12 | Month | 22 | Day |
2024 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029207