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To assess the efficacy and safety of lenalidomide combined with rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisone (r2-chop) in the initial treatment of DEL-DLBCL. The primary endpoint is the complete response rate, and the second endpoints are survival time (OS and PFS) and overall response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R2-CHOP(Lenalidomide,Rituximab,cyclophosphamide,hydroxyldaunorubicin,Vincristine,Prednisone)) | Drug | Lenalidomide:25mg po QN,d1-10 Rituximab: 375mg/m2, ivdrip, d1 Cyclophosphamide: 750mg/m2, iv or ivdrip, d1 Hydroxyldaunorubicin: 50mg/m2, iv or ivdrip, d1 Vincristine: 1.4 mg/m2 , iv(max:2mg), d1 Prednisone: 60mg/m2, po, d1-5 every 3 weeks was a course of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | The complete response rate | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free. | Up to 3 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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YES
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OS was defined as time from study registration to death, and otherwise censored at time last known alive.
| Up to three years |
| Objective Remission Rate | CR+PR | Up to 2 years |