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| Name | Class |
|---|---|
| The First Affiliated Hospital of Nanchang University | OTHER |
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This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.
The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orelabrutinib+R-CHOP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib+R-CHOP | Drug | Orelabrutinib 150mg qd PO. Rituximab 375 mg/m2 IV on Day 0 of each 21-day cycle. The CHOP include cyclophosphamide, doxorubicin/Epirubicin/liposomal doxorubicin, vincristine/Vindesine, and prednison. |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as the proportion of patients with a best response of CR or PR | up to 24 weeks |
| 2 years progression-free survival | 2 years progression-free survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up without relapsing |
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Inclusion Criteria:
Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma
Exclusion Criteria:
• systemic lymphoma involved CNS.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zengjun Li | Contact | 13642138692 | zengjunli@163.com | |
| Dan Liu | Contact | 13256139207 |
| Name | Affiliation | Role |
|---|---|---|
| zengjun Li | Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Ailliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years] |
| 2 years overall survival | 2 years overall survival was calculated from the date of therapy until death from lymphoma or 2-year follow-up alive | From date of receiving the first dose until the date of death from any cause,assessed up to 2 years |
| The occurrence of adverse events and serious adverse events | Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0. | up to 30 months |
| Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences | Recruiting | Jinan | Shandong | China |
|