diffuse large B -cell lymphoma
Conditions
Interventions
Case series:bendamustine,pomalidomide,sintilimab
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) patients aged 18-75 years old, regardless of gender; 2) Patients who are not suitable for transplantation or unwilling to transplant 3) Recurrent or refractory diffuse large B-cell lymphoma was confirmed by histopathology with at least two previous lines of therapy; 4) ECOG-PS 0-2; 5) At least one measurable lesion according to Lugano 2014 criteria 6) Bone marrow hematopoietic function is basically normal: White blood cell count > 3000/uL, absolute neutrophil count =1.5x109/L (granulocyte colony-stimulating factor is allowed), platelet count =75x109/L (blood transfusion up to this minimum platelet count is allowed), hemoglobin =8.0g/dL (pre-infusion of red blood cells or recombinant human erythropoietin is allowed). If the peripheral blood indexes were abnormal due to lymphoma invading bone marrow or spleen, the researchers could determine whether the patients were eligible. 7) Normal function of major organs: serum bilirubin =2.0×ULN, serum ALT and AST=2.5×ULN, serum Cr=1.5 ×ULN; 8) A life expectancy of =3 months; 9) The patient is fully informed and signs the informed consent
Exclusion criteria
Exclusion criteria: 1) Primary and secondary central nervous system lymphoma; 2) Clinically significant heart disease, including unstable angina pectoris, acute myocardial infarction within 6 months prior to screening, congestive heart failure (NYHA) grade III or IV heart function; 3) previous use of PD-1 containing therapy; 4) Subjects with acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons (HBV-DNA = 104); 5) Pregnant or lactating women; 6) Active bacterial, fungal and/or viral infections that cannot be controlled by systemic treatment; 7) With a history of severe neurological or psychiatric problems, including dementia or epilepsy; 8) Other malignancies within the last 5 years or at the same time, excluding cured basal cell carcinoma of the skin or cervical carcinoma in situ, early prostate cancer that does not require systemic treatment, or early breast cancer that requires surgery alone; 9) Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the trial or results evaluation ; 10) Patients deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate ;progression free survival;safety; | — |
Countries
China
Contacts
Public ContactZhigang,Peng
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed