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

Phase 3

• Conditions: Lymphoma, Large B-Cell, Diffuse; Transplantation; Chemotherapy
• Interventions: Drug: PD-1 Inhibitor Tislelizumab maintenance therapy

• Registration Number: NCT04799314
• Lead Sponsor: Ruijin Hospital

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).

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Study Start: 2021-04-01
• Primary Completion: 2023-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD-1 Inhibitor maintenance	PD-1 Inhibitor Tislelizumab maintenance therapy	PD-1 Inhibitor Tislelizumab maintenance therapy dose 200mg frequency 1 time for 2 months duration 2 years

Primary Outcome Measures

Name	Time	Method
progression-free survival	2-years after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
complete remission rate	90 days after 12 cycles of treatment (each cycle is 8 weeks).	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
overall survival	2-years after enrollment	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.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China