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

Study Overview
=================
Brief 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).

Detailed Description
-----------------
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).

Official Title
-----------------
PD-1 Inhibitor Tislelizumab Maintenance Therapy in Relapsed/Refractory DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety.

Conditions
-----------------
Lymphoma, Large B-Cell, Diffuse, Transplantation, Chemotherapy

Intervention / Treatment
-----------------
* Drug: PD-1 Inhibitor Tislelizumab maintenance therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female, aged 18-65; relapsed/refractory DLBCL patients after autologous stem cell transplantation; Laboratory tests (blood tests, liver and renal function) meet the following requirements: Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value; Renal function: serum creatinine 44-133 mmol / L; The score of ECOG was 0-2; The subject or his legal representative must provide written informed consent before the special examination or procedure of the study. Exclusion Criteria: Pregnant or lactating women; Severe complications or infection; Lymphoma involving central nervous system; Participate in other clinical trials at the same time; According to the judgment of the researcher, the patients who are not suitable for this study were selected.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-1 Inhibitor maintenance<br>PD-1 Inhibitor Tislelizumab maintenance therapy dose 200mg frequency 1 time for 2 months duration 2 years | Drug: PD-1 Inhibitor Tislelizumab maintenance therapy<br>* PD-1 Inhibitor Tislelizumab maintenance therapy<br>|
| No Intervention: No intervention<br>No intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first. | 2-years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria | 90 days after 12 cycles of treatment (each cycle is 8 weeks). | 
| overall survival | Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first. | 2-years after enrollment |