PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT
PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to
 investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed
 diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell
 transplantation (ASCT).
This is a multicenter, randomized controlled, prospective clinical trial. The objective is to
 investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed
 diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell
 transplantation (ASCT). 94 patients were randomly divided into two groups according to the
 ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period
 (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the
 enrollment).
Inclusion Criteria:

 1. Male and female, aged 18-65;

 2. newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after
 autologous stem cell transplantation;

 3. Laboratory tests (blood tests, liver and renal function) meet the following
 requirements:

 1. Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥
 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L

 2. Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5
 × upper limit of normal value;

 3. Renal function: serum creatinine 44-133 mmol / L;

 4. The score of ECOG was 0-2;

 5. The subject or his legal representative must provide written informed consent before
 the special examination or procedure of the study.

 Exclusion Criteria:

 1. Pregnant or lactating women;

 2. Severe complications or infection;

 3. Lymphoma involving central nervous system;

 4. Participate in other clinical trials at the same time;

 5. According to the judgment of the researcher, the patients who are not suitable for
 this study were selected.