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: 13.1 Level: PT Classification code 10054133 Term: Prophylaxis of nausea and vomiting System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Aloxi
Product Name: Palonosetron hydrochloride
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Aloxi
CAS Number: 135729-61-2
Other descriptive name: PALONOSETRON HYDROCHLO
Sponsors
Helsinn Healthcare SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the efficacy of single doses of intravenous (IV) palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in individual study cycles and the maintenance of such efficacy through repeated and consecutive study cycles, when administered for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) to patients with Non Hodgkin’s Lymphomas receiving repeated (a minimum of two up to a maximum of four) and consecutive single-day moderately emetogenic chemotherapy (MEC) cycles.;Secondary Objective: A further objective is to evaluate the safety of IV palonosetron in initial and repeated consecutive MEC cycles for up to four study cycles.;Primary end point(s): The main efficacy parameter in this study is the proportion of patients considered to have achieved a CR (defined as no emetic episode and no rescue medication) during the first 120 hours after administration of chemotherapy (overall 0 to 120 hour interval). The proportion of patients achieving CR for the 0 to 120 hour interval (and exact 95% confidence interval) will be summarized for each study cycle for the IV palonosetron 0.25 mg dose. Other efficacy parameters are the proportion of patients considered to have achieved a CR during the 0 to 24 hour and during the 24 to 120 hour intervals after administration of chemotherapy. The proportion of complete responders (and exact 95% confidence interval) in these time periods will be summarized for each study cycle for the IV palonosetron 0.25 mg dose. | — |
Countries
Czech Republic, Germany, Italy
Outcome results
None listed