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A pilot study of systemic high dose methotrexate for intraocular lymphoma after intravitreal methotrexate to prevent the development of central nerve system lymphoma

A pilot study of systemic high dose methotrexate for intraocular lymphoma after intravitreal methotrexate to prevent the development of central nerve system lymphoma - A pilot study of high dose methotrexate for intraocular lymphoma after intravitreal methotrexate

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003921
Enrollment
10
Registered
2010-07-17
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular lymphoma

Interventions

5 cycles of systemic methotexate every 2 weeks after intravitreal methotrexate injection

Sponsors

Tokyo Medical and Dental University, Department of Hematology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
2 years disease free survival

Secondary

MeasureTime frame
Rate of adverse events, and relapse rate (intraocular, central nerve system and other lesion)

Countries

Japan

Contacts

Public ContactMinako Jinta

Tokyo Medical and Dental University Department of Hematology

ara.hema@tmd.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026