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This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional Rituximab Injection | Experimental |
| |
| Involved Site Radiation Therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Intralesional Rituximab Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative occurrence rate of complications of grade ≥2 within 2 years after the start of treatment | 2 years after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Local control rate of ocular adnexal MALT lymphoma 2 years after the start of treatment | 2 years after the start of treatment | |
| 2-year Time-to-next-treatment rate | 2 years after the start of treatment |
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Inclusion Criteria:
Age between 18 to 75 years old.
Meets the WHO diagnostic criteria for ocular adnexal MALT lymphoma, with a comprehensive diagnosis based on pathology (including pathological morphology, immunophenotype, and genetic testing), clinical manifestations, and biological characteristics:
Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of ocular adnexal MALT lymphoma are included.
Informed and signed informed consent.
Exclusion Criteria:
If both eyes of a patient meet the inclusion criteria, the right eye will be selected for participation in the study, while the left eye will receive the same treatment, but its data will not be included in the research. Each patient can have only one eye participating in the study.
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| Involved Site Radiation Therapy |
| Radiation |
Involved Site Radiation Therapy |
|
| 2-year overall survival rate | 2 years after the start of treatment |
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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