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A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL
R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone | Experimental | Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days Hydration, antibiotics, allopurinol, nutritional supplements, and so on. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrednisoLONE 50 MG | Drug | Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| (treatment-related mortality rate; TRM) | treatment-related mortality rate | an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| IMWG fragility score before and after pre-phase treatment | International Myeloma Working Group,( IMWG) | an average of 1 year |
| TRM and RR according to IMWG fragility score | International Myeloma Working Group,( IMWG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Busan | Sue-gu | 60542 | 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 |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| an average of 1 year |
| response rate; RR | response rate | an average of 1 year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | safety | an average of 1 year |
| Incidence of neutropenic fever | Incidence of neutropenic fever | an average of 1 year |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |