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A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.
The objective was to evaluate the efficacy and safety of R-CDOP regimen in the initial treatment of Patients with at least one of the following high tumor burden, and to provide a basis for the application of Doxorubicin hydrochloride liposome.
At least 3 nodal sites (each with a diameter greater than 3 cm) ; Nodal or extranodal mass > 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female > 15cm, male > 16cm) ; Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT Total Metabolic Tumor Volume (TMTV)>220cm3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CDOP | Experimental | Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CDOP | Combination Product | Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Percentage of Complete remission (CR), Partial remission (PR), and stable disease (SD), referred to Lugano 2014. | 24 months |
| Progression-free survival | Progression-free survival(PFS) is defined as the time from the date of enrollment to the date of first documentation of progressive disease (PD) or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ou BAI, doctor | Contact | 13039046656 | oubai16@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | 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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| 24 months |
| Overall survival | Overall survival(OS) is defined as the time from the date of enrollment to the date of death from any cause. | 60 months |
| Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | 24 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |