Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Study Overview
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Brief Summary
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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).

Official Title
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Phase II Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Conditions
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Chemotherapy-Induced Nausea and Vomiting, Non Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Palonosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, >18 years of age; Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification); Patients candidates to a initial chemotherapy treatment; ECOG performance status of 0-1; Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification) on Day 1; Written informed consent; Female of childbearing potential must be using reliable contraceptive measures; Acceptable hepatic and renal functions; Willing and able to complete the patient diary. Exclusion Criteria: Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine, streptozotocin, cyclophosphamide >1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification); Diagnosis of Hodgkin's Disease or Leukemia; Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation; Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days; Have received any investigational drugs within 30 days before study entry; Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation); Prior treatment with Palonosetron; Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity; Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase; Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis; Clinically relevant electrolyte abnormalities; Have a known hypersensitivity to 5HT3 receptor antagonists; Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy; Female patients who are pregnant or breast feeding; Inability to understand or cooperate with the study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: palonosetron<br> | Drug: Palonosetron<br>* Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin's lymphoma, Quality of life, Chemotherapy toxicity, aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy