UMIN-CTR Clinical Trial

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
Email	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
Email	neuros@clin.med.tokushima-u.ac.jp

Sponsor
Institute	Department of Neurosurgery, Institute of Health Biosciences,The University of Tokushima Graduate School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014315