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

Chemotherapy Induced Nausea and Vomiting Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02205164
Study type Interventional
Source Associazione Salentina Angela Serra
Contact Nicola Di Renzo, MD
Email direnzo.ematolecce@libero.it
Status Recruiting
Phase Phase 2
Start date October 2011
Completion date October 2014
View Details
See also
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Completed NCT01362530 - A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208) Phase 3
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Not yet recruiting NCT04873284 - Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients N/A
Completed NCT00642512 - Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Phase 3
Recruiting NCT02097823 - Pilot Study of Olanzapine and Aprepitant to Prevent Nausea and Vomiting in Children Receiving Chemotherapy Phase 2
Completed NCT01402024 - Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy Phase 3
Completed NCT00211601 - Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041) N/A
Completed NCT05792228 - A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting N/A
Withdrawn NCT01596426 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years Phase 1
Withdrawn NCT01596413 - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years Phase 1