UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057483 |
|---|---|
| Receipt number | R000065611 |
| Scientific Title | A survey on the use of the MATRix regimen for Central Nervous System Lymphoma in Japan |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 13:35:13 |
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Basic information
Public title
A survey on the use of the MATRix regimen for Central Nervous System Lymphoma in Japan
Acronym
A survey on the use of the MATRix regimen for CNSL in Japan
Scientific Title
A survey on the use of the MATRix regimen for Central Nervous System Lymphoma in Japan
Scientific Title:Acronym
A survey on the use of the MATRix regimen for CNSL in Japan
Region
| Japan |
Condition
Condition
Primary central nervous system lymphoma or secondary central nervous system lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and effectiveness of the MATRix regimen in patients with PCNSL or SCNSL in clinical practice in Japan.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and frequency of adverse events and adverse reactions
Key secondary outcomes
1) Effectiveness of the MATRix regimen (overall response rate, progression-free survival, overall survival)
2) Treatment details of the MATRix regimen (number of cycles, dose per cycle)
3) Clinical laboratory values
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with PCNSL or SCNSL before March 31, 2024
2) Patients who were at least 18 years of age at the time of initiation of the MATRix regimen
3) Patients who have received at least one cycle of the MATRix regimen (HD-MTX, HD-AraC, rituximab, and standard-dose thiotepa as remission induction therapy) for PCNSL or SCNSL
Key exclusion criteria
Patients determined to be ineligible for the study by the principal investigator or sub-investigators
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Eisei |
| Middle name | |
| Last name | Kondo |
Organization
Kawasaki Medical School
Division name
Department of Hematology
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama
TEL
086-462-1111
eisei-k@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Kakiuchi |
Organization
Mebix, Inc.
Division name
Clinical Operations
Zip code
105-0001
Address
Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo, 105-0001, Japan
TEL
03-4362-4500
Homepage URL
matrix2022@mebix.co.jp
Sponsor or person
Institute
THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Pharma 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
Kawasaki Medical School, Ethics committee
Address
577, Matsushima, Kurashiki, Okayama
Tel
086-462-1111
kmsrec@med.kawasaki-m.ac.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
| 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-Retrospective observational study
-Method of recruitment: All patients diagnosed with PCNSL or SCNSL on before March 31, 2024 who meet the selection criteria and do not meet the exclusion criteria.
-Main study items: patient background, medical history, comorbidities, stage of PCNSL or SCNCL, MATRix regimen details and that of effectiveness, adverse events, and survival information.
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=R000065611
