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)

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT01018758
First received: November 23, 2009
Last updated: November 24, 2009
Last verified: November 2009
  Purpose

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).


Condition Intervention Phase
Chemotherapy-Induced Nausea and Vomiting
Non Hodgkin's Lymphoma
Drug: Palonosetron
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) [ Time Frame: 0-120 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of Complete Response [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
  • number of emetic episodes [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
  • presence of nausea graded according to Likert scale [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
  • time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
  • patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS) [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: No ]
  • toxic effects of Palonosetron [ Time Frame: within the first 24 h after chemotherapy and 24-120 h ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: July 2006
Study Completion Date: July 2008
Arms Assigned Interventions
Experimental: palonosetron Drug: Palonosetron
Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018758

Locations
Italy
Gruppo Italiano Studio Linfomi
Modena, Italy, 41100
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Investigators
Principal Investigator: Nicola Di Renzo, MD Gruppo Italiano Studio Linfomi
  More Information

No publications provided

Responsible Party: Nicola Di Renzo, Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier: NCT01018758     History of Changes
Other Study ID Numbers: NHLPal
Study First Received: November 23, 2009
Last Updated: November 24, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Studio Linfomi:
Non-Hodgkin's lymphoma
Quality of life
Chemotherapy toxicity
aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, Non-Hodgkin
Nausea
Vomiting
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Emetics
Palonosetron
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014