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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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Research purpose: To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design: Single-arm, multicenter, prospective study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-mini-MCOP | Experimental | Rituximab :375 mg/m2,ivgtt,d0; Mitoxantrone Liposome : The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2,ivgtt,d1; Vincristine :1mg,ivgtt,d1; Prednisone:40 mg/m2,po.,d1-5; Q3W(Every 3 Weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-miniMCOP:Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone | Drug | Rituximab :375 mg/m2,ivgtt,d0; Mitoxantrone Liposome : The first dose level: 6mg/m2, ivgtt, d1; The second dose level: 8mg/m2, ivgtt, d1; The third dose level: 10mg/m2, ivgtt, d1; Cyclophosphamide :400 mg/m2,ivgtt,d1; Vincristine :1mg(,ivgtt,d1; Prednisone:40 mg/m2,po.,d1-5; Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Complete response rate at the end of induction | At the end of Cycle 2 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response (CR+PR) Rate (ORR) | Overall Response (CR+PR) rate at the end of induction | At the end of Cycle 2 (each cycle is 21 days) |
| Duration of response (DOR) | From the date when criteria for response are met (CR or PR) until the date of progression or relapse. Patients without relapse or progression or death from other causes will be censored at their last assessment date (24 months from response date) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Yang | Contact | 13683260156 | medart@126.com |
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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 |
|---|---|
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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|
| Progression-free survival (PFS) | Time between the date of enrolment and the date of disease progression, relapse or death from any cause (12,24 months) |
| Overall Survival (OS) | Time between the date of enrolment and the date of death from any cause (12,24, 36 and 48 months) |
| Event Free Survival (EFS) | From the date of enrolment to the date of disease progression, relapse from CR, initiation of subsequent systemic anti-lymphoma therapy after the least 6 cycles of RI-CHOP (each cycle is 21 days), or death whichever occurs first (24, 36 and 48 months) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |