Diffuse large B-cell lymphoma
Conditions
Interventions
Experimental group:Azacytidine: 75mg/m2, d1-d5
Rituximab: 375mg/m2, d6
Gemcitabine: 1g/m2, d7
Oxaliplatin: 100mg/m2, d7
Sponsors
Daping Hospital, Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: (1) Sign a written informed consent and voluntarily join the study; (2) Over the age of 18, male or female; (3) Histologically confirmed as DLBCL; (4) Subjects must be patients with relapsed (disease progression confirmed after recent treatment) or refractory (failure to achieve complete or partial response after recent treatment) DLBCL; (5) There must be at least one measurable lesion (defined by Lugano 2014 criteria), which is defined as the longest diameter of the lymph node lesion in the CT cross-sectional image > 1.5cm; The longest diameter of extranodal lesion was >1.0cm; And FDG-PET positive lesions; (6) Life expectancy >=12 weeks
Exclusion criteria
Exclusion criteria: (1) Allergic history to azacytidine, CD20 monoclonal antibody, gemcitabine, oxaliplatin; (2) poor compliance or inability to follow regularly; (3) Patients with potentially life-threatening or severe organ dysfunction who are deemed unfit to participate in the study by the investigator; (4) A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases; (5) Pregnant or lactating women; (6) There are other factors, as determined by the investigator, that may have led to the forced termination of the study, such as other serious medical conditions (including mental illness) requiring co-treatment, alcohol, substance abuse, family or social factors, factors that may have affected the safety or compliance of the subjects;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate, ORR;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission, CR;Partial Remission, PR;Progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactDongfeng Zeng
Daping Hospital, Army Medical Center of PLA
Outcome results
None listed