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Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?

Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma? - Is monthly administration of rituximab useful in ocular adnexal mucosa-associated lymphoid tissue lymphoma?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013117
Enrollment
25
Registered
2014-02-10
Start date
2014-02-10
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

Ocular adnexal mucosa-associated lymphoid tissue-type lymphoma (OAL)

Interventions

Monthly administration of rituximab is performed for ocular adnexal mucosa-associated lymphoid tissue lymphoma(MALT).

Sponsors

Hiroshima University hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histopathologically, the patient with ocular adnexal extranodal marginal zone B-cell lymphoma (MZL) of mucosa-associatd lymphoid tissue (MALT) type lymphoma 2) The patient who has measurable lesion(major-axis:>1.5cm by computed tomography [CT]) 3) A patient age is 80 and below or 20 and over 4) PS is a patient of 0-2. 5) The patient who has the good function of main internal organs (marrow, the heart, a lung, liver, and kidney) - The number of neutrophils : more than 1,000/mm3 - The number of blood platelets : more than 75,000/mm3 - AST (GOT) : less than 2.5 times of an institution standard value maximum - ALT (GPT) : less than 2.5 times of an institution standard value maximum - Total bilirubin : less than 1.5 times of an institution standard value maximum - Serum creatinine : less than 1.5 times of an institution standard value maximum - Oxyecoia-partial-pressure (pulse oximeter measurement is possible) PaO2 >=65mmHg - The unusual view of an electrocardiogram which requires medical treatment is not seen. 6) The patient who wishes the participation in an examination independently and by whom the participating consent document was got in written form

Exclusion criteria

Exclusion criteria: 1) The patient who has clear infection (virus infection is included) 2) The patient who has critical complications (hepatic insufficiency or renal insufficiency) 3) The patient who has a merger or anamnesis of critical cardiac disease (example: myocardial infarction, ischemic heart disease) 4) The patient who has critical digestive symptoms (advanced or serious nausea and vomiting, or diarrhea etc.) 5) The patient who shows a hepatitis B surface antigen, a HCV antibody, or HIV antibody-positive 6) The patient who has critical bleeding tendencies (diffuse-intravascular-coagulation syndrome etc.) 7) The patient who has clinical symptoms which make permeation in a central nervous system, or it suspect 8) The patient who has generation of heat of 38 or more degree C(however, in the case of tumor fever, it removes) 9) The patient who has interstitial pneumonia, pulmonary fibrosis, and pulmonary emphysema, or the patient accepted in the past 10) The patient who has active double cancer 11) The patient who has autoimmune hemolytic anemia, or the patient accepted in the past 12) A patient with the past of the critical hypersensitivity to mouse protein origin products, or an anaphylactic reaction 13) A pregnant woman or the patient that may have become pregnant, the patient under breast-feeding 14) The patient who cannot consent to contraception regardless of man and woman 15) In addition, the patient who judged that a doctor was unsuitable

Design outcomes

Primary

MeasureTime frame
PFS

Countries

Japan

Contacts

Public ContactTatsuji Mino

Hiroshima University hospital hematology

kmmihara@hiroshima-u.ac.jp0822575861

Outcome results

None listed

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