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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/12/07 |
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 |
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Condition | ||
Condition | CCR4-positive relapsed or refractory adult T cell leukemia-lymphoma | |
Classification by specialty |
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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 | |
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Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 | ||||||
kouichi.kawamura.1r@kyowakirin.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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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 |
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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. |
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Results date posted |
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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%). |
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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. |
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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. |
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Recruitment status | Completed | ||||||
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Other | |
Other related information | Surveillance following all-case surveillance method |
Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029207 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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