mucosa-associated lymphoid tissue lymphoma
Conditions
Interventions
single arm:rituximab combined with local radiotherapy
Sponsors
Anhui Provincial Cance Hospital
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed mucosa-associated lymphoid tissue lymphoma (MALT); 2. Males and females >=14 years of age; 3. Adequate performance status, ECOG score < 2 4. Have not received prior anticancer therapy for MALT lymphoma; 5. Presence of at least one radiographically measurable lesion (as defined by the NHL Lugano stage); 6. Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
Exclusion criteria
Exclusion criteria: 1. History of prior malignancy except for the following: (1) Malignancy has been treated with curative intent, with no evidence of active disease for more than 2 years prior to screening, and with a low risk of recurrence in the opinion of the treating physician. Note: Only subjects receiving hormonal therapy may participate as long as other eligibility criteria are met; (2) Adequately treated lentigo maligna melanoma with no current evidence of disease, or adequately controlled non-melanoma skin cancer; (3) Adequately treated carcinoma in situ with no current evidence of disease; 2. Evidence and history of central nervous system (CNS) lymphoma involvement; 3. Major surgical procedure within 14 days prior to the first dose of study drug; 4. Significant uncontrolled cardiovascular disease at screening; 5. Absolute neutrophil count (ANC) 2 ULN; or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 ULN, if the investigator believes that abnormal liver function is caused by this disease; 7. Creatinine > 2 ULN, if the investigator believes that abnormal liver function is caused by this disease can be; 8. Uncontrolled active systemic fungal, bacterial, viral, or other infection; 9. Known history of human immunodeficiency virus (HIV) infection; 10. Presence of uncontrolled HBV or HCV infection; 11. Other conditions considered inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS rate of 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;CRR;PR;SD;OS rate of 2 years;AE;SAE; | — |
Countries
China
Contacts
Public ContactDing Kai Yang
Anhui Provincial Cance Hospital
Outcome results
None listed