Phase II randomized multicenter study of multiple doses of palonosetron plus aprepitant versus multiple doses of palonosetron alone in preventing chemotherapy-induced nausea and vomiting in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome receiving multiple days chemotherapy

INTERVENTION: Trade Name: ALOXI*1FL 250MCG 5ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: PALONOSETRON CAS Number: 135729‐56‐5 Current Sponsor code: Aloxi Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25‐ Trade Name: EMEND*1CPS 125MG+2CPS 80MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: APREPITANT CAS Number: NA Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 125‐ CONDITION: patients with Acute Myeloid leukemia or high‐risk Myelodisplastic syndrome according to IPSS score treated with AML‐like multiple days chemotherapy regimen ; MedDRA version: 14.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 ‐ Blood and lymphatic system disorders Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase Primary end point(s): the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase. Secondary Objective: 1.Complete Response (single days only) 2.Complete Control (defined as no emetic episode, no need for rescue medication, with a maximum grade of mild nausea); 3.Percentage of patients emesis‐free (no emetic episodes); 4.Presence of nausea graded according to Likert scale (none, mild, moderate and severe); 5.Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first); 6.patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS); 7.Safety profile. Timepoint(s) of evaluation of this end point: Patients will be under evaluation from Day 1 (the first day of chemotherapy) until 48 hrs after the last dose of chemotherapy. Patients will be evaluated for overall phase (from 0 hour until 48 hrs after the last dose of chemotherapy) and separately on single days. INCLUSION CRITERIA: •Diagnosis of Acute Myeloid Leukaemia or High‐risk MDS according to IPSS •Patient eligible for AML‐like induction therapy •Candidate for multiple–days chemotherapy (minimum 3 days) •Age > 18 years •ECOG 0‐2 •Not pregnant or nursing •Must be able to complete the patient’s diary •Provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14 SECONDARY OUTCOME: Secondary end point(s): 1.Complete Response (single days only) 2.Complete Control (defined as no emetic episode, no need for rescue medication, with a maximum grade of mild nausea); 3.Percentage of patients emesis‐free (no emetic episodes); 4.Presence of nausea graded according to Likert scale (none, mild, moderate and severe); 5.Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first); 6.patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS); 7.Safety profile. Timepoint(s) of evaluation of this end point: Patients will be under evaluation from Day 1 (the first day of chemotherapy) until 48 hrs after the last dose of chemotherapy. Patients will be evaluated for overall phase (from 0 hour until 48 hrs after the last dose of chemotherapy) and separately on single days.