UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059928 |
|---|---|
| Receipt number | R000068532 |
| Scientific Title | TECENTRIQ Drug Use Surveillance (ENKL) |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/12/01 09:00:57 |
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Basic information
Public title
TECENTRIQ Drug Use Surveillance (ENKL)
Acronym
TECENTRIQ Drug Use Surveillance (ENKL)
Scientific Title
TECENTRIQ Drug Use Surveillance (ENKL)
Scientific Title:Acronym
TECENTRIQ Drug Use Surveillance (ENKL)
Region
| Japan |
Condition
Condition
ENKL
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The following items should be confirmed under the actual conditions of the use of Tecentriq intravenous infusion (hereinafter referred to as this drug) for patients with relapsed or refractory extranodal NK/T-cell lymphoma and nasal type (ENKL) aged 12 to 18 years (hereinafter referred to as children)
Primary objective: Calculation of response rate based on the judgment of the attending physician
Secondary objective: Calculation of the rate of side effects
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate based on the judgment of the attending physician
Key secondary outcomes
Percentage of adverse reaction cases (by MedDRA PT, severity, and grade)
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Enrolled Cases: All pediatric patients with relapsed or refractory ENKL who plan to use this drug from the date of addition of indication to relapsed or refractory ENKL (September 19, 2025) to the end of the enrollment period
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takemoto |
Organization
Chugai Pharmaceutical Co. Ltd
Division name
Safety Science 2 Department
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
takemotosny@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murayama |
Organization
Chugai Pharmaceutical Co. Ltd
Division name
Safety Science 2 Department
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068532
