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Patients initially are randomized into 2 arms:
Arm I: R-DA-EPOCH; Arm II: R-CEOP90;
Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.
Patients initially are randomized into 2 arms:
Arm I: R-DA-EPOCH; Arm II: R-CEOP90;
Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.
The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has similar efficacy compared to that with R-DA-EPOCH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I:R-DA-EPOCH | Active Comparator | Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles. |
|
| Arm II:R-CEOP90 | Experimental | Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-DA-EPOCH | Drug | R-DA-EPOCH-21 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate | Two-year survival |
| Measure | Description | Time Frame |
|---|---|---|
| complete response | (physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianda Hu, Prof. | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | 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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Open Label
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|
| R-CEOP90 | Drug | R-CEOP90 treatment for DLBCL patients between 16 to 60 years with high risk. Patients who meet the criteria for ASCT after reaching CR or PR will undergo ASCT, while those who do not meet the criteria or refuse to undergo ASCT, will continue with 2 cycles of immunochemotherapy. |
|
| 6 cycles |
| overall survival | Survival time is calculated in months from day of enrollment in the study until death, as appropriate | Two-year survival |
| Incidence of Treatment-Emergent Adverse Events | Adverse Events (AEs) occurring during the protocol-specified reporting period are documented. | During the treatment |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |