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 (NHLPal)

Gruppo Italiano Studio Linfomi

Status and phase

Completed

Phase 2

Conditions

Chemotherapy-Induced Nausea and Vomiting

Non Hodgkin's Lymphoma

Treatments

Drug: Palonosetron

Study type

Interventional

Funder types

Other

Identifiers

NCT01018758

NHLPal

Details and patient eligibility

About

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).

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.