preventing chemotherapy-induced nausea and vomiting in untreated patients with aggressive Non Hodgkin?s Lymphomas who underwent moderately emetogenic chemotherapy. MedDRA version: 9.1 Level: HLT Classification code 10028817 Term: Nausea and vomiting symptoms
Conditions
Interventions
Product Name: palonosetron
Pharmaceutical Form: Solution for injection
INN or Proposed INN: palonosetron
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Sponsors
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary end point is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the whole study period (the first 5 days following administration of the first cycle of chemotherapy; 0-120 h).;Secondary Objective: evaluated during the Acute Phase (within the first 24 h after chemotherapy) and during the Delayed Phase (24-120 h) over the whole study period, include the following: the rate of Complete Response; the rate of Complete Control (defined as no emetic episode, and no need for rescue medication, with a maximum grade of mild nausea); number of emetic episodes; presence of nausea graded according to Likert scale; time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first); patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS); and safety.;Primary end point(s): to evaluate the efficacy and safety of a single dose of Palonosetron IV in preventing chemotherapy-induced nausea and vomiting (CINV) induced by moderately emetogenic chemotherapy agents used for the treatment of aggressive Non Hodgkin?s Lymphomas (NHL) (REAL classification). | — |
Countries
Italy
Outcome results
None listed