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

• Conditions: patients with Acute Myeloid leukemia or high-risk Myelodisplastic syndrome according to IPSS score treated with AML-like multiple days chemotherapy regimen; MedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003823-36-IT
• Lead Sponsor: ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

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