To hear about similar clinical trials, please enter your email below
Trial Title:
RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma
NCT ID:
NCT06064344
Condition:
Primary Ocular Adnexal MALT Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Non-Hodgkin
Stomach Neoplasms
Rituximab
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Intralesional Rituximab Injection
Arm group label:
Intralesional Rituximab Injection
Intervention type:
Radiation
Intervention name:
Involved Site Radiation Therapy
Description:
Involved Site Radiation Therapy
Arm group label:
Involved Site Radiation Therapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age between 18 to 75 years old.
2. 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:
1. Clinical criteria: ① Extranodal lymphoma occurring in the ocular adnexa; ②
Localized mass.
2. Pathological criteria:
1. Histopathology: Morphological features that recapitulate Peyer's patches,
including: ① Lymphoepithelial lesions; ② Reactive follicles; ③ Marginal zone
cells and/or monocytoid B cells; ④ Small lymphocyte-like cells; ⑤ Plasma cells;
⑥ Scattered transformed blasts (centroblast-like, immunoblast-like cells).
2. Immunophenotype: Tumor cells express B-cell-related antigens: SIgM+, CIg +/-,
CD5-, CD10-, CD23-, cyclin DI, CD43 +/-, CD19, CD20, CD22, and CD79a positive.
3. Genetic features: Absence of BCL-1 and BCL-2 gene rearrangements, presence of
IgH/L gene rearrangements; possible +3 and t(11, 18)(q21, q21).
3. Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of
ocular adnexal MALT lymphoma are included.
4. Informed and signed informed consent.
Exclusion Criteria:
1. Based on the TNM staging of ocular adnexal lymphoma, patients staged as T4 of ocular
adnexal MALT lymphoma.
2. Patients who have previously received local or systemic radiation, chemotherapy, or
drug treatment specifically for ocular adnexal MALT lymphoma.
3. Presence of cataract and is anticipated to require surgical treatment within a
certain period after enrollment; existing cataract affects visual field testing and
fundoscopic examination; vision affected by cataract is <20/40.
4. In addition to the need for treatment of ocular adnexal MALT lymphoma, there is a
requirement for other ocular procedures (e.g., full-thickness corneal transplant or
retinal surgery) or an anticipated need for another emergent ocular surgery.
5. Concurrent other ocular diseases: Including corneal abnormalities or existing
corneal infections, iridocorneal endothelial syndrome, anterior segment dysgenesis,
true microphthalmos, uveitis, glaucoma, ocular trauma, and retinal disorders such as
central retinal vein occlusion, central retinal artery occlusion, retinal
detachment, etc.
6. Need for long-term use of local or systemic steroids.
7. Patients already enrolled in other drug clinical trials.
8. Pregnant or breastfeeding women.
9. Serious systemic diseases: Advanced cardiac disease, kidney disease, respiratory
diseases, or other malignant tumors, etc.
10. Inability to understand the research content.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 7, 2023
Completion date:
October 6, 2027
Lead sponsor:
Agency:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Agency class:
Other
Source:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06064344
