Early-stage MALT lymphoma
Conditions
Interventions
Test cohort:Rituximab combined with ultralow-dose radiotherapy (4Gy)
Sponsors
Jiangsu Province Hospital, the First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed mucosa-associated lymphoid tissue (MALT) lymphoma; 2. Age >=18 years, without gender restrictions; 3. ECOG performance status score <=2; 4. No prior systemic anticancer therapy for MALT lymphoma (biopsy/surgical resection for pathological diagnosis is permitted); 5. Lugano stage I-II disease; 6. Ability to understand the study's purpose and risks, and provide signed and dated informed consent with authorization for use of protected health information.
Exclusion criteria
Exclusion criteria: 1. MALT lymphoma with large cell transformation; 2. Pregnant or lactating women; 3. Concurrent malignancy (except non-melanoma skin cancer); 4. Significant uncontrolled cardiovascular disease at screening, with NYHA Class III-IV heart failure requiring exclusion; 5. Uncontrolled active systemic fungal, bacterial, viral, or other infections at screening, including known history of human immunodeficiency virus (HIV) infection; 6. Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate (CRR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Disease control rate (DCR);Overall survival (OS);Progression-free survival (PFS);Safety; | — |
Countries
China
Contacts
Public ContactLei Fan
Jiangsu Province Hospital, the First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed