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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Inhibitor maintenance | Experimental | PD-1 Inhibitor Tislelizumab maintenance therapy dose:200mg frequency:1 time for 2 months duration:2 years |
|
| No intervention | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 Inhibitor Tislelizumab maintenance therapy | Drug | PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| overall survival |
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Inclusion Criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, doctor | Contact | +862164370045 | zwl_trial@163.com | |
| Pengpeng Xu, doctor | Contact | +862164370045 | pengpeng_xu@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200020 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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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 |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |