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 - Palonosetron in NH

• Conditions: preventing chemotherapy-induced nausea and vomiting in untreated patients with aggressive Non Hodgkin?s Lymphomas who underwent moderately emetogenic chemotherapy.; MedDRA version: 9.1Level: HLTClassification code 10028817Term: Nausea and vomiting symptoms

• Registration Number: EUCTR2006-003189-33-IT
• Lead Sponsor: G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

·Male or female, ³ 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 reported in the Appendix 2) on Day 1;
·Written informed consent;
·Female of childbearing potential must be using reliable contraceptive measures;
·Acceptable hepatic function (£2 times the upper limit of normal for liver transaminases) and renal function (creatinine <1.5 times the upper limit of normal);
·Willing and able to complete the patient diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Highly emetogenic chemotherapy (containing cisplatin, mechloretamine, streptozotocin, cyclophosphamide ³1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification reported in the Appendix 3);
·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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified