Overview

PD-1 Inhibitor Tislelizumab Maintenance Therapy in R/R DLBCL Patients After ASCT

Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ruijin Hospital
Treatments:
Immune Checkpoint Inhibitors
Criteria
Inclusion Criteria:

1. Male and female, aged 18-65;

2. relapsed/refractory 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.