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This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| palonosetron | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) | 0-120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| rate of Complete Response | within the first 24 h after chemotherapy and 24-120 h | |
| number of emetic episodes | within the first 24 h after chemotherapy and 24-120 h | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Di Renzo, MD | Gruppo Italiano Studio Linfomi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gruppo Italiano Studio Linfomi | Modena | 41100 | Italy |
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| presence of nausea graded according to Likert scale |
| within the first 24 h after chemotherapy and 24-120 h |
| time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) | within the first 24 h after chemotherapy and 24-120 h |
| patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS) | within the first 24 h after chemotherapy and 24-120 h |
| toxic effects of Palonosetron | within the first 24 h after chemotherapy and 24-120 h |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
|---|---|
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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