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| Name | Class |
|---|---|
| Fifth Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Gansu Cancer Hospital | OTHER |
| First Affiliated Hospital of Shantou University Medical College | OTHER |
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This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted.
The primary endpoint is the 2-year event-free survival (EFS) rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orelabrutinib in combination with R-CHOP | Experimental | Patients with CD5 positive diffuse large B-cell lymphoma will receive orelabrutinib in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle). After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib Oral Tablet | Drug | Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year event-free survival (EFS) rate | To investigate the preliminary anti-tumor efficacy | Defined as the proportion of patients without disease progression, treatment discontinuation, or death for any reason within 24 months of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | To investigate the preliminary anti-tumor efficacy | Up to 8 cycles (each cycle is 21 days) |
| Disease-free survival (DFS) | To investigate the preliminary anti-tumor efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| The correlation of gene mutations and alterations in relevant signaling pathways with the efficacy and survival in CD5-positive DLBCL | To explore the correlations between gene mutations and response and prognosis | Through study completion, an average of 2 years |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | 02087342823 | caiqq@sysucc.org.cn | |
| Yi Xia, MD. PhD. | Contact | 02087342823 | xiayi@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, | Recruiting | Guangzhou | China | 51000 | 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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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| C571759 | R-CHOP protocol |
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| Southern Medical University, China |
| OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
| Shenzhen People's Hospital | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| First People's Hospital of Zhaoqing | OTHER |
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| R-CHOP Protocol | Drug | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone |
|
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| From date of the first complete response until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Objective response rate (ORR) | To investigate the preliminary anti-tumor efficacy | Up to 8 cycles (each cycle is 21 days) |
| Progression-free survival (PFS) | To investigate the preliminary anti-tumor efficacy | From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Overall survival (OS) | To investigate the preliminary anti-tumor efficacy | From the date of enrollment until the date of death from ant cause, assessed up to 24 months |
| Number of participants with adverse events (AE) and severe adverse events (SAE) as assessed by CTCAE v5.0 | To identify the incidence of AE and SAE | Through study completion, an average of 2 years |
| Gansu Cancer Hospital | Recruiting | Lanzhou | Gansu | China |
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| Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | 510060 | China |
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| Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| First People's Hospital of Guangzhou | Recruiting | Guangzhou | Guangdong | China |
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| Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | China |
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| Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
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| First Affiliated Hospital of Shantou University Medical College. | Recruiting | Shantou | Guangdong | China |
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| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | China |
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| Zhaoqing First People's Hospital | Recruiting | Zhaoqing | Guangdong | China |
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| Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | 510060 | China |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |