UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003921 |
|---|---|
| Receipt number | 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 22:50:40 |
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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
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
ara.hema@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Department of Hematology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004709
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
