Chemotherapy, Lymphoma, Large B-Cell, Diffuse, Transplantation
Conditions
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).
Interventions
PD-1 Inhibitor Tislelizumab maintenance therapy
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactWeili Zhao, doctor
Backup ContactPengpeng Xu, doctor
Outcome results
None listed