UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042120 |
|---|---|
| Receipt number | R000048046 |
| Scientific Title | A database study to understand the current treatment patterns and efficacy of high-dose methotrexate-based therapy in Japanese patients with Primary central nervous system lymphoma |
| Date of disclosure of the study information | 2020/10/14 |
| Last modified on | 2025/10/07 10:35:36 |
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Basic information
Public title
A database study to understand the current treatment patterns and efficacy of high-dose methotrexate-based therapy in Japanese patients with Primary central nervous system lymphoma
Acronym
A database study to understand the current treatment patterns and efficacy of high-dose methotrexate-based therapy in Japanese patients with PCNSL
Scientific Title
A database study to understand the current treatment patterns and efficacy of high-dose methotrexate-based therapy in Japanese patients with Primary central nervous system lymphoma
Scientific Title:Acronym
A database study to understand the current treatment patterns and efficacy of high-dose methotrexate-based therapy in Japanese patients with PCNSL
Region
| Japan |
Condition
Condition
Primary central nervous system lymphoma
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify changes in the efficacy of repeated HD-MTX -based therapy in patients with primary central nervous system lymphoma (PCNSL), changes in the treatment-free period following repeated treatment with HD-MTX -based therapy, treatment-free period in patients who switched from HD-MTX -based therapy to a regimen other than HD-MTX -based therapy, and the number of retreatment doses, etc. will be clarified using the MDV database.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment-free period from HD-MTX -based therapy to retreatment with HD-MTX -based therapy
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Have a prescription record of HD-MTX
- Age 20 years or more on the day of the index
etc.
Key exclusion criteria
- Patients whose data period before the index is less than 6 months (183 days)
- Patients with a follow-up period of less than 12 months (365 days)
- Patients with a cancer recurrence flag on the initial hospitalization record
etc.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical Affairs
Zip code
103-0023
Address
4-9-11 Nihonbashi Honcho, Chuo-ku, Tokyo
TEL
03-5640-3701
hi.matsumoto@ono.co.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical Affairs
Zip code
103-0023
Address
4-9-11 Nihonbashi Honcho, Chuo-ku, Tokyo
TEL
03-5640-3701
Homepage URL
ic.matsumoto@ono-pharma.com
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ONO PHARMACEUTICAL CO., LTD.
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel
06-6263-2992
n.nishiwaki@ono.co.jp
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
| 2020 | Year | 10 | Month | 14 | 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
431
Results
Among patients with PCNSL who received HD-MTX-based first-line therapy, those treated with combination therapy (n=248) showed significant differences compared to those treated with monotherapy (n=183) in the following aspects:
Younger (median age: 67 vs. 70 years)
More patients had normal cognitive functions.
Higher activities of daily living scores
Of the 431 patients, 23.0% (99/431) received second-line treatment. Among these, 46 received HD-MTX-based therapy and 53 received nonMTX-based therapy.
Results date posted
| 2025 | Year | 10 | Month | 07 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the MDV database. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require approval by IRB.
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048046
