CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 150 enrolled
Drug / intervention
Ondansetron +1 moredrug
Likely dose
Ondansetron 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01031498
NCT01031498Phase 2Completed
CompareCT.gov

Phase II, Open, Randomized Comparative Trial of Two Different Schedules of Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting in Patients With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine

M.D. Anderson Cancer Center·interventional·Posted Dec 14, 2009·Updated Aug 7, 2012

In Brief

A Phase 2 clinical trial evaluating Ondansetron and Palonosetron for Acute Myelogenous Leukemia and Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia, Chemotherapy-induced Nausea and Vomiting
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 14, 2009
Enrollment StartSep 1, 2005
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.6 years ago

Interventions

Ondansetrondrug

8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.

Palonosetrondrug

Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy. Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on Days 1, 3, and 5 of cytarabine chemotherapy, 30 minutes before chemotherapy.