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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003921
Receipt No. R000004709
Scientific Title A pilot study of systemic high dose methotrexate for intraocular lymphoma after intravitreal methotrexate to prevent the development of central nerve system lymphoma
Date of disclosure of the study information 2010/07/17
Last modified on 2010/07/16

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Basic information
Public title A pilot study of systemic high dose methotrexate for intraocular lymphoma after intravitreal methotrexate to prevent the development of central nerve system lymphoma
Acronym A pilot study of high dose methotrexate for intraocular lymphoma after intravitreal methotrexate
Scientific Title A pilot study of systemic high dose methotrexate for intraocular lymphoma after intravitreal methotrexate to prevent the development of central nerve system lymphoma
Scientific Title:Acronym A pilot study of high dose methotrexate for intraocular lymphoma after intravitreal methotrexate
Region
Japan

Condition
Condition Intraocular lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a more effective therapy for intraocular lymphoma, we plan and perform a study investigating efficacy and safety of systemic high dose methotrexate injection after intravitreal methotrexate injection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2 years disease free survival
Key secondary outcomes Rate of adverse events, and relapse rate (intraocular, central nerve system and other lesion)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 5 cycles of systemic methotexate every 2 weeks after intravitreal methotrexate injection
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 A. Patients of intraocular lymphoma without CNS involvement (examined by CT scan, MRI and lumbar puncture), diagnosed according to the following criteria:
1) positive for characteristic ocular symptoms and findings of lymphoma
2) pathologically diagnosed as lymphoma
3) positive for IgH gene clonality detected by PCR assay or flow cytometry
1 with 2 or 3
B. Patients whose written informed consent can be obtained
Key exclusion criteria (1) Lymphoma with extra-CNS involvement
(2) Women during pregnancy
(3) History of serious allergic reactions, for example, asthma, urticaria, etc. by medical agents
(4) Contraindication for methotrexate
(a) History of serious adverse reactions by methotrexate
(b) Severe dysfunction of liver, kidney, and heart
(c) Pleural effusion or ascites except for those with little amount, which cannot be performed pleural or abdominal puncture
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayako Arai
Organization Tokyo Medical and Dental University
Division name Department of Hematology
Zip code
Address 1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Minako Jinta
Organization Tokyo Medical and Dental University
Division name Department of Hematology
Zip code
Address 1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
Homepage URL
Email ara.hema@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Department of Hematology
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University, Department of Hematology
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
Address
Tel
Email

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
2010 Year 07 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 Open public recruiting
Date of protocol fixation
2006 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 16 Day
Last modified on
2010 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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