Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-28 @ 12:47 AM
Study NCT ID:
NCT01018758
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2009-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2009-11-23', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)', 'timeFrame': '0-120 hours'}], 'secondaryOutcomes': [{'measure': 'rate of Complete Response', 'timeFrame': 'within the first 24 h after chemotherapy and 24-120 h'}, {'measure': 'number of emetic episodes', 'timeFrame': 'within the first 24 h after chemotherapy and 24-120 h'}, {'measure': 'presence of nausea graded according to Likert scale', 'timeFrame': 'within the first 24 h after chemotherapy and 24-120 h'}, {'measure': 'time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)', 'timeFrame': 'within the first 24 h after chemotherapy and 24-120 h'}, {'measure': 'patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)', 'timeFrame': 'within the first 24 h after chemotherapy and 24-120 h'}, {'measure': 'toxic effects of Palonosetron', 'timeFrame': 'within the first 24 h after chemotherapy and 24-120 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Non-Hodgkin's lymphoma", 'Quality of life', 'Chemotherapy toxicity', "aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy"], 'conditions': ['Chemotherapy-Induced Nausea and Vomiting', "Non Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, \\>18 years of age;\n* Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification);\n* Patients candidates to a initial chemotherapy treatment;\n* ECOG performance status of 0-1;\n* 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;\n* Written informed consent;\n* Female of childbearing potential must be using reliable contraceptive measures;\n* Acceptable hepatic and renal functions;\n* Willing and able to complete the patient diary.\n\nExclusion Criteria:\n\n* 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);\n* Diagnosis of Hodgkin's Disease or Leukemia;\n* Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation;\n* Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days;\n* Have received any investigational drugs within 30 days before study entry;\n* 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);\n* Prior treatment with Palonosetron;\n* Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity;\n* Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase;\n* Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis;\n* Clinically relevant electrolyte abnormalities;\n* Have a known hypersensitivity to 5HT3 receptor antagonists;\n* Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy;\n* Female patients who are pregnant or breast feeding;\n* Inability to understand or cooperate with the study procedures."}, 'identificationModule': {'nctId': 'NCT01018758', 'acronym': 'NHLPal', 'briefTitle': "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", 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Studio Linfomi'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'NHLPal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'palonosetron', 'interventionNames': ['Drug: Palonosetron']}], 'interventions': [{'name': 'Palonosetron', 'type': 'DRUG', 'description': 'Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.', 'armGroupLabels': ['palonosetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Gruppo Italiano Studio Linfomi', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Nicola Di Renzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gruppo Italiano Studio Linfomi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Studio Linfomi', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nicola Di Renzo', 'oldOrganization': 'Gruppo Italiano Studio Linfomi'}}}}