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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen sequential therapy as a first-line treatment for patients with intermediate-to-high risk diffuse large B-cell lymphoma who had incomplete remission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCMOP | Experimental | RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitoxantrone hydrochloride liposome injection | Drug | Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To evaluate the efficacy of anti-tumor | At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | To evaluate the efficacy of anti-tumor | At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days) |
| Duration of Response (DOR) | To evaluate the efficacy of anti-tumor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ou Bai, PHD | Contact | 13039046656 | oubai16@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| RiTUXimab Injection | Drug | RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle. |
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| Cyclophosphamid | Drug | Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. |
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| Vincristine | Drug | Vincristine (1.4 mg/m^2,maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle. |
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| Prednisolone | Drug | Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle. |
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| CR or PR up to data cut-off (up to approximately 2 years) |
| Progression-free survival (PFS) | To evaluate the efficacy of anti-tumor | Baseline up to data cut-off (up to approximately 2 years) |
| Overall survival (OS) | To evaluate the efficacy of anti-tumor | Baseline up to data cut-off (up to approximately 2 years) |
| Treatment emergent adverse events (TEAEs) | The incidence and severity of adverse events assessed by CTCAE v5.0 | The first dose up to 21 or 28 days after the last dose |
| 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 |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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