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
Conditions
Interventions
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)
Co
Sponsors
ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: •AML or HR-MDS therapy-related •Active infection requiring intravenous antibiotics •Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for = 5 years •Unacceptable hepatic function (>2 times the upper limit of normal for liver transaminases) and renal function (creatinine >1.5 times the upper limit of normal) unless disease-related •Myocardial infarction within the past 6 months •Psychiatric or CNS disorders interfering with ability to comply with study protocol •Known hypersensitivity to 5-HT3 antagonists and their components •CSF involvement •Pre-existing nausea or vomiting - treatment with experimental drug within the last month - Uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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.;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.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Contacts
Public ContactTrial Office
SC Ematologia - P.O. "Vito Fazzi" - Lecce
Outcome results
None listed