UMIN-CTR Clinical Trial
| 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 |
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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
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
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
yukie.tsuji.dq@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
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
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/10.1111/ejh.13220
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
| 2024 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029207
