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The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.
Mitoxantrone Hydrochloride Liposome Injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. The investigator´s phaseâ… study has shown that the drug´s toxicity is manageable and the tolerable does is 20 mg/m2. The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitoxantrone 12 mg/m2 | Experimental | Mitoxantrone Hydrochloride Liposome Injection 12 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5ï¼… glucose injection on the first day during a treatment phase of 3 weeks. |
|
| Mitoxantrone 16 mg/m2 | Experimental | Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5ï¼… glucose injection on the first day during a treatment phase of 3 weeks. |
|
| Mitoxantrone 20mg/m2 | Experimental | Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5ï¼… glucose injection on the first day during a treatment phase of 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide 750 mg/m2 will be infused intravenously once 1-2 minutes in 20-30 ml saline on the first day during a treatment phase of 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective response rate) | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huaqing Wang, Ph.D | Tianjin People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin people's Hospital | Tianjin | 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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| 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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| Vincristine | Drug | Vincristine 0.3-0.5 mg/ml will be infused intravenously once about 5 minutes in saline on the first day during a treatment phase of 3 weeks. |
|
| Prednisone | Drug | Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks. |
|
| 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 |