lymphoma
Conditions
Interventions
experimental group:Chidamide combined with rituximab
Sponsors
Tianjin Union Medical Center
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged >= 65 years, be able to understand and voluntarily sign informed consent; 2. Patients with CD20 positive diffuse large B-cell lymphoma were confirmed histologically; 3. The patient is a patient with recurrent refractory lymphoma who needs at least 2 cycles of rituximab combined with chemotherapy; Or patients who are unable or unwilling to use chemotherapy drugs due to disease and serious toxic and side effects of chemotherapy; 4. According to Lugano classification, the patient must have at least one two-dimensional measurable lesion; 5. The functions of heart, liver, kidney, lung and other major organs meet the following criteria within 7 days before treatment: (1)Blood routine examination standard (without blood transfusion within 14 days): 1) Hemoglobin (HB) >= 90g/L; 2) Neutrophil absolute value (ANC) >= 1.5 x 10^9/L; 3) Platelet >= 80 x 10^9/L; (2)Biochemical examination shall meet the following standards: 1) Total bilirubin (TBIL) = 60ml / min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%); 6. ECOG quality of life score is 0-2; 7. Expected survival >= 3 months; 8. The distance from the application of other HDACi inhibitors is >= 6 months, and sidabelamide has not been used; >= 3 months from the last application of rituximab.
Exclusion criteria
Exclusion criteria: 1. Those who received radiotherapy and chemotherapy within 1 month before enrollment; 2. Severe coagulation disorder and serious impairment of heart, lung, liver, kidney and other organ functions; 3. The expected survival time is less than 3 months; 4. Patients with active uncontrolled infection, including HIV, cytomegalovirus (CMV) infection, hepatitis B or hepatitis C; 5. It is known that lymphoma involves the central system or is combined with other serious or even fatal malignant tumors; 6. Poor compliance, failure to use drugs according to regulations or incomplete data; Allergic constitution or known allergy to the test drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Quality of life score; | — |
Countries
China
Contacts
Public ContactWang Huaqing
Tianjin Union Medical Center
Outcome results
None listed