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This study aims to explore whether adding immunotherapy bridging treatment for low-risk refractory/relapsed B-NHL can demonstrate better outcomes, in order to find the most effective treatment plan for low-risk patients.
In the immunotherapy bridging treatment group, zanubrutinib ± radiotherapy will be used as the bridging treatment regimen, while those without bridging treatment will not receive bridging medications. Both groups will determine subsequent maintenance treatment based on efficacy at D28. Patients achieving complete response (CR) will not receive maintenance therapy, while those with partial response (PR) will be given oral zanubrutinib + PD-1 inhibitor for 2 years. Patients with stable disease (SD) or disease progression (PD) will not be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy bridging treatment | Experimental | Zanubrutinib ± radiotherapy was used as the bridging therapy in the immunobridging treatment group, a Follow-up maintenance treatment was determined according to the efficacy of D28 in the two groups. Patients with complete response (CR) were given no maintenance treatment, while patients with partial response (PR) were given Zanubrutinib orally plus PD-1 inhibitor for 2 years. Patients with stable SD or progressive PD were excluded from this study |
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| no bridging treatment | Active Comparator | The control group will not receive bridging treatment. Maintenance treatment will be consistent with the experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zanubrutinib | Drug | zanubrutinib 160 mg BID orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) at 3-month | Complete response rate at 3-month is defined as the incidence of subjects achieving complete response (CR) at 3-month after CAR-T infusion according to the Lugano Classification, as determined by study investigators. | 3 months post CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) on D28 | CRR on D28 after infusion is defined as the incidence of subjects achieving complete response (CR) on day 28 after CAR-T infusion according to the Lugano Classification, as determined by study investigators. | 28 days post CAR-T infusion |
| Objective remission rate (ORR) on D28 |
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Inclusion Criteria:
Exclusion criteria:
Patients with any of the following conditions will not be included in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhao wei li, doctor Degree | Contact | +862164370045 | Ext.610707 | zwl_trial@163.com |
| yan zi xun, doctor degree | Contact | +862164370045 | Ext.610707 | yzx12119@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C000707970 | tislelizumab |
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| CAR-T | Drug | CAR-T Cell therapy |
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| Bridging radiotherapy | Radiation | For patients in the experimental group, the decision regarding radiotherapy will depend on whether the specific lesions are suitable. |
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| Tislelizumab | Drug | 200mg IV Q3-4W |
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Objective remission rate (ORR) on D28 is defined as the incidence of either a CR or a partial response (PR) on day 28 after CAR-T infusion per the Lugano Classification as determined by study investigators. |
| 28 days post CAR-T infusion |
| Objective remission rate (ORR) at 3-month | Objective remission rate (ORR) at 3-month is defined as the incidence of either a CR or a partial response (PR) at 3-month after CAR-T infusion per the Lugano Classification as determined by study investigators. | 3 months post CAR-T infusion |
| Progression-Free Survival (PFS) | PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause. | 2 years post CAR-T infusion |
| Overall Survival (OS) | OS is defined as the time from CAR-T infusion to the date of death from any cause. | 2 years post CAR-T infusion |
| CAR-T cell expansion | CAR-T cell expansion is to evaluate the proliferation and persistence of CAR-T cells in the patient's body following infusion. It is measured through quantitative assays, such as flow cytometry or qPCR, to track CAR-T cell levels in peripheral blood at predefined intervals. | 2 years post CAR-T infusion |
| Adverse Events rate | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | 2 years post CAR-T infusion |