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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)

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting, Non Hodgkin's Lymphoma

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Palonosetron

About this trial

This is an interventional prevention trial for Chemotherapy-Induced Nausea and Vomiting focused on measuring Non-Hodgkin's lymphoma, Quality of life, Chemotherapy toxicity, aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Gruppo Italiano Studio Linfomi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

palonosetron

Arm Description

Outcomes

Primary Outcome Measures

overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)

Secondary Outcome Measures

rate of Complete Response

number of emetic episodes

presence of nausea graded according to Likert scale

time to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)

patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)

toxic effects of Palonosetron

Full Information

NCT ID

NCT01018758

First Posted

November 23, 2009

Last Updated

November 24, 2009

Sponsor

Gruppo Italiano Studio Linfomi

1. Study Identification

Unique Protocol Identification Number

NCT01018758

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

Acronym

NHLPal

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Gruppo Italiano Studio Linfomi

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-Induced Nausea and Vomiting, Non Hodgkin's Lymphoma

Keywords

Non-Hodgkin's lymphoma, Quality of life, Chemotherapy toxicity, aggressive Non Hodgkin's Lymphomas treated with moderately emetogenic chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

palonosetron

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Intervention Description

Palonosetron will be given as an intravenous bolus at the dose of 250 micrograms over 30 seconds beginning 30 minutes before chemotherapy.

Primary Outcome Measure Information:

Title

overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication)

Time Frame

0-120 hours

Secondary Outcome Measure Information:

Title

rate of Complete Response

Time Frame