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
Phase 2
Completed
- Conditions
- Chemotherapy-Induced Nausea and VomitingNon Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT01018758
- Lead Sponsor
- Gruppo Italiano Studio Linfomi
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description palonosetron Palonosetron -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 toxic effects of Palonosetron within the first 24 h after chemotherapy and 24-120 h 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
Trial Locations
- Locations (1)
Gruppo Italiano Studio Linfomi
🇮🇹Modena, Italy