Back to resultsPD-1 Inhibitor Tislelizumab Maintenance Therapy in R/R DLBCL Patients After ASCT
Primary Purpose
Lymphoma, Large B-Cell, Diffuse, Transplantation, Chemotherapy
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PD-1 Inhibitor Tislelizumab maintenance therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse
Eligibility Criteria
Inclusion Criteria:
- Male and female, aged 18-65;
- relapsed/refractory 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 Criteria:
- 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.
Sites / Locations
- Ruijin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PD-1 Inhibitor maintenance
No intervention
Arm Description
PD-1 Inhibitor Tislelizumab maintenance therapy dose 200mg frequency 1 time for 2 months duration 2 years
No intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
complete remission rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04799314
Brief Title
PD-1 Inhibitor Tislelizumab Maintenance Therapy in R/R DLBCL Patients After ASCT
Official Title
PD-1 Inhibitor Tislelizumab Maintenance Therapy in Relapsed/Refractory DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Transplantation, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD-1 Inhibitor maintenance
Arm Type
Experimental
Arm Description
PD-1 Inhibitor Tislelizumab maintenance therapy dose 200mg frequency 1 time for 2 months duration 2 years
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
PD-1 Inhibitor Tislelizumab maintenance therapy
Intervention Description
PD-1 Inhibitor Tislelizumab maintenance therapy
Primary Outcome Measure Information:
Title
progression-free survival
Description
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.
Time Frame
2-years after enrollment
Secondary Outcome Measure Information:
Title
complete remission rate
Description
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
90 days after 12 cycles of treatment (each cycle is 8 weeks).
Title
overall survival
Description
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.
Time Frame
2-years after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female, aged 18-65;
relapsed/refractory 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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, doctor
Phone
+862164370045
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu, doctor
Phone
+862164370045
Email
pengpeng_xu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, doctor
Organizational Affiliation
Ruijin Hospital Shanghai, Shanghai, China, 200020
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PD-1 Inhibitor Tislelizumab Maintenance Therapy in R/R DLBCL Patients After ASCT
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