Status:
UNKNOWN
PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT
Lead Sponsor:
Ruijin Hospital
Conditions:
Lymphoma, Large B-Cell, Diffuse
Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- Male and female, aged 18-65;
- newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) 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
- 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.
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04789434
Start Date
July 9 2021
End Date
July 1 2024
Last Update
November 22 2021
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020