NCT02205164

Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

Phase II Randomized Study of Multiple Doses of Palonosetron Plus Aprepitant Versus Multiple Doses of Palonosetron Alone in Preventing CINV in Patients With Newly Diagnosed AML or High-risk MDS Receiving Multiple Days Chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Associazione Salentina Angela Serra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.

Detailed description

This is an open-label, randomized, comparative, multicenter phase II study in patients with AML scheduled to receive multiple days chemotherapy. Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. Below are described the details for both antiemetic regimens: PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment. PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

Conditions

• Chemotherapy Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron + Aprepitant	Aloxi 0.25mg Emend 125/80/80 mg
DRUG	Palonosetron	Aloxi 0.25mg

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-08-01
• Completion: 2014-10-01
• First posted: 2014-07-31
• Last updated: 2014-07-31

Locations

11 sites across 1 country: Italy