UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057474 |
|---|---|
| Receipt number | R000065660 |
| Scientific Title | LUNSUMIO injection Drug Use Surveillance (Relapsed or Refractory Follicular Lymphoma) |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 09:32:59 |
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Basic information
Public title
LUNSUMIO injection Drug Use Surveillance (Relapsed or Refractory Follicular Lymphoma)
Acronym
LUNSUMIO injection Drug Use Surveillance (Relapsed or Refractory Follicular Lymphoma)
Scientific Title
LUNSUMIO injection Drug Use Surveillance (Relapsed or Refractory Follicular Lymphoma)
Scientific Title:Acronym
LUNSUMIO injection Drug Use Surveillance (Relapsed or Refractory Follicular Lymphoma)
Region
| Japan |
Condition
Condition
The objective is to explore risk factors for cytokine release syndrome (CRS) under the actual use status of Lunsumio intravenous infusion (Hereinafter referred to as this drug) for relapsed or refractory follicular lymphoma.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to explore risk factors for cytokine release syndrome (CRS) under the actual use status of Lunsumio intravenous infusion (Hereinafter referred to as this drug) for relapsed or refractory follicular lymphoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CRS Risk Factors
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
Subjects to be registered: Patients with relapsed or refractory follicular lymphoma who are scheduled to use this drug for the first time or who use this drug for the first time at the institutions with which a contract for this survey has been concluded, and whose number of consecutive patients reached the number of contracted cases from the date of initial marketing in Japan. Subjects for whom survey forms are collected: Patients who used this drug among subjects to be registered.
Key exclusion criteria
None
Target sample size
120
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 | 04 | 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 | 01 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065660
