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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04789434
Other study ID # NHL-PD1-1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


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
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