PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT

Chemotherapy Clinical Trial

Official title:

PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04789434
• Other study ID #: NHL-PD1-1
• Status: Recruiting
• Phase: Phase 3
• Start date: July 9, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2021
• Source: Ruijin Hospital
• Contact: Weili Zhao, doctor
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• PD-1 Inhibitor Tislelizumab maintenance therapy
PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	complete remission rate	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria	2-years after enrollment
Secondary	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