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This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | R-CMOP group |
|
| Control group | Active Comparator | R-CHOP group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CMOP Regimen | Drug | Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year event-free survival (EFS) rate assessed by the independent review committee | To investigate the antitumor efficacy | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment. |
| RP2D(Phase Ib) | Phase II Recommended Dose | Cycle 1 in R-CMOP group (28 days) |
| DLT(Phase Ib) | Dose-limiting toxicity | Cycle 1 in R-CMOP group (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year event-free survival (EFS) rate assessed by the investigators | To investigate the anti-tumor efficacy | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment. |
| AE and SAE (Phase Ib) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 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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| R-CHOP Regimen | Drug | Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally |
|
Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib |
| Up to 24 weeks |
| 2-year Progression-free survival(PFS) | To investigate the antitumor efficacy | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment |
| 2-year Overall survival(OS) | To investigate the antitumor efficacy | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment |
| Objective response rate (ORR) | To investigate the antitumor efficacy | Up to 24 weeks |
| Complete response rate (CRR) | To investigate the antitumor efficacy | Up to 24 weeks |
| Gansu Provincial Cancer Hospital | Not yet recruiting | Lanzhou | Gansu | China |
|
| The Fifth Affiliated Hospital of Guangzhou Medical University. | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The Affiliated Hospital of Guangdong Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Shenzhen People's Hospital | Not yet recruiting | Shenzhen | Guangdong | China |
|
| The Fifth Affiliated Hospital of Sun Yat-sen University | Recruiting | Zhuhai | Guangdong | China |
|
| Guangxi Zhuang Autonomous Region Cancer Hospital | Not yet recruiting | Guilin | Guangxi | China |
|
| Ganzhou Cancer Hospital | Not yet recruiting | Ganzhou | Jiangxi | China |
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| Jiangxi Provincial Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| Beijing Tongren Hospital | Not yet recruiting | Beijing | China |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |