Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single Intravenous Dose of Palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin’s Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy

• Conditions: Prevention of moderately emetogenic CINV in up to four repeated and consecutive single-day MEC cycles administered to patients with Non-Hodgkin’s Lymphomas.; MedDRA version: 13.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2008-007827-14-DE
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-20
• Last Update Posted: 15 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be included in this study, or to continue participating in any of the repeated study cycles, the patients must meet the following criteria:
1.Male or female =18 years of age
2.Histologically or cytologically confirmed Non-Hodgkin’s Lymphoma
3.Patient scheduled to receive single-day MEC as one of the following regimens (at each study cycle) in at least two repeated and consecutive chemotherapy cycles:
•CHOP or R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone, with or without Rituximab)
•ProMACE-CytaBOM (cyclophosphamide, doxorubicin, etoposide, cytarabine, bleomycin, vincristine, methotrexate, leucovorin and prednisone)
Note: Consecutive chemotherapeutic cycles must employ the same chemotherapeutic regimen. This can include changes in dose (adjustments of dose) of the MEC agent(s) or discontinuation of low, minimal or non-emetogenic concomitant chemotherapeutic agents as clinically appropriate, with no highly emetogenic agents added. For more details refer to Section 7.7.2 of protocol.
4.Naïve to cancer chemotherapy (i.e. the patient has no chemotherapeutic history)
5.A Karnofsky Performance Status of = 50%, at each study cycle
6.Signed written informed consent (with additional legal representative’s consent or parent’s consent if required)
7.Patient with a known hepatic, renal or cardiovascular impairment, including cardiac conduction interval abnormalities, and scheduled to receive the above mentioned chemotherapeutic agents, may be enrolled in this study or continue the participation in each of the repeated study cycles at the discretion of the Investigator
8.Female patient of childbearing potential must be using reliable contraceptive measures with a negative urine pregnancy test before any study treatment administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients are excluded from the enrollment in this study or from the participation in any of the subsequent repeated study cycles if they meet any of the following criteria:
1.Inability to understand or co-operate with the study procedures, at any study cycle
2.Any investigational drugs (other than those given in this study) administered within 30 days before intake of study medication, at each study cycle
3.Any drug with potential anti-emetic efficacy administered within 24 hours of the intake of study medication, at each study cycle. Examples of these drugs are listed in the protocol Appendix E. Patients taking topical or inhaled steroids may be enrolled in the study
4.Any vomiting, retching, or NCI Common Toxicity Criteria Grade 2 or 3 nausea in the 24 hours preceding chemotherapy, at each study cycle
5.Treatment with commercial palonosetron (Aloxi®, Onicit® and Paloxi®) within 2 weeks prior to the intake of study treatment, at each study cycle
6.Enrollment in a previous study with palonosetron
7.Ongoing vomiting from any organic etiology, at each study cycle
8.Presence of a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication (prophylactic anticonvulsant medication for patients free of seizure activity is allowed), at each study cycle
9.IV Palonosetron 0.25 mg not administered in consecutive MEC cycles (see Section 7.1)
10.Patient with AIDS-related B-cell Lymphoma
11.Patient testing positive to the HBsAg test at the Screening Visit.
12.Scheduled to receive:
•Moderately emetogenic chemotherapy between the Screening Visit and the first study medication administration, on Days 2 to 5 of each study cycle, or on any day between two consecutive study cycles
•Highly emetogenic chemotherapy, orally or intravenously: any dose of cisplatin, dacarbazine, streptozotocin, carmustine, mechlorethamine, hexamethylmelamine or procarbazine; or cyclophosphamide =1500 mg/m2 between the Screening Visit and the first study medication administration or during the study
•Radiotherapy of upper abdomen or cranium or total body irradiation within 7 days prior to the first study medication administration or during the study
•Any low-level emetogenic chemotherapeutic agent during Days 2 to 5 of each study cycle, if this chemotherapy, in the Investigators’ opinion, requires co-administration of additional anti-emetics. Administration of low-level emetogenic chemotherapy without additional anti-emetics is allowed on Days 2 to 5
13.Known contraindication to 5-HT3 receptor antagonists, at each study cycle.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified