Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01018758
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01018758
Study Brief:
Protocol Section:
NCT01018758