UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012602 |
|---|---|
| Receipt number | R000014315 |
| Scientific Title | High-dose methotrexate with rituximab in patients with primary central nervous system lymphoma |
| Date of disclosure of the study information | 2013/12/17 |
| Last modified on | 2019/12/28 10:47:36 |
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Basic information
Public title
High-dose methotrexate with rituximab in patients with primary central nervous system lymphoma
Acronym
High-dose methotrexate with rituximab in patients with primary central nervous system lymphoma
Scientific Title
High-dose methotrexate with rituximab in patients with primary central nervous system lymphoma
Scientific Title:Acronym
High-dose methotrexate with rituximab in patients with primary central nervous system lymphoma
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
The purpose of this study is to evaluate the effect of rituximab in patients with primary CNS lymphoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival, progression-free survival, KPS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm1:treated with high-dose MTX + Rituximab
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
Patients were required to have a histologically proven CD20+ B-cell CNS non-Hodgkin lymphoma.
Before the start of treatment patients were evaluated by MRI,PET,CT
Key exclusion criteria
serum creatinine >1.3mg/dl, creatinine clearance <75ml/minute, white blood cell count <3000 per dL
platelet count <100000 per dL
positive for hepatitis B surface antigens, hepatitis C seropositivity
pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takagi |
| Middle name | |
| Last name | Takagi |
Organization
Institute of Health Biosciences,The University of Tokushima Graduate School
Division name
Neurosurgery
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7149
neuros@clin.med.tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Nakajima |
Organization
Institute of Health Biosciences,The University of Tokushima Graduate School
Division name
Neurosurgery
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7149
Homepage URL
neuros@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Institute of Health Biosciences,The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Institute of Health Biosciences,The University of Tokushima Graduate School
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
Crinical trial center for developmental therapeutics
Address
2-50-1,Kuramoto-cho,city of Tokushima
Tel
0886339294
awachiken@tokushima-u.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
| 2013 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2019 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014315
