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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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This study is an Open-labeled, multicenter Phase II study of Bortezomib for maintenance therapy in patients with high risk diffuse large B cell lymphoma (DLBCL). Primary objective is 3 years relapse free survival (RFS) and Secondary objectives are 3 years overall survival (OS), 3 years event free survival (EFS),Toxicities profiles, Quality of Life (FACT&GOG-Ntx)
High-intermediate or high risk in IPI has a long-term chance of cure in the range about 50% in patients with DLBCL treated by R-CHOP. These high risk patients should be considered for additional new treatment to standard R-CHOP or investigational approaches in the context of clinical trials that are designed to ensure that potentially curative therapy.
Bortezomib has shown activity in vitro against DLBCL-derived cell lines. Single-agent bortezomib or chemotherapy combined bortezomib are feasible in follicular, mantle cell, marginal zone lymphoma and DLBCL with manageable toxicities. Bortezomib enhances the activity of chemotherapy in non-GCB but not GCB DLBCL, and provide a rational therapeutic approach based on genetically distinct DLBCL subtypes.
High CR/CRu rate with bortezomib with standard R-CHOP suggests it may be a good backbone for additional maintenance leading to durable response. However, there is no study of bortezomib as maintenance therapy after treated with R-CHOP in high risk patients with DLBCL. So we applied additional bortezomib as maintenance therapy in order to assess improving efficacy and survival rates in high risk patients with non-GCB DLBCL who had been confirmed CR after treated with R-CHOP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib | Experimental | bortezomib 1.3mg/m2 subcutaneous on day 1 and15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3years relapse free survival | 3years relapse free survival will be assessed after starting maintenance therapy for 1year and then following up for 3years. | from the date of first drug administration until the date of last follow up, assessed up to 4years |
| Measure | Description | Time Frame |
|---|---|---|
| 3years overall survival | 3years overall survival will be assessed after starting maintenance therapy for 1year and then following up for 3years. | from the date of first drug administration until the date of last follow up, assessed up to 4years |
| 3years event free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wonseog Kim, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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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 |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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3years event free survival will be assessed after starting maintenance therapy for 1year and then following up for 3years. |
| from the date of first drug administration until the date of last follow up, assessed up to 4years |
| Toxicity profiles | Safety profiles will be evaluated using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. | from the date of first drug administration until the date of the 30th day after last cycle of chemotherapy |
| Quality of life scale | Quality of life will be assessed after starting maintenance therapy for 1year and then following up for 3years by using FACT&GOG-Ntx. | from the date of first drug administration until the date of last follow up, assessed up to 4years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |