CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 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/NCT00954941
NCT00954941Phase 2Completed
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Comparative Trial Ondansetron Alone Versus Combination of Ondansetron Plus Aprepitant for Prevention of Nausea and Vomiting With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine

M.D. Anderson Cancer Center·interventional·Posted Aug 7, 2009·Updated Jun 25, 2015

In Brief

A Phase 2 clinical trial evaluating Ondansetron and Aprepitant for Hematologic Diseases and 3 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Diseases, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Chronic Myelogenous Leukemia
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 7, 2009
Enrollment StartNov 1, 2009
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.9 years ago

Interventions

Ondansetrondrug

8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.

Aprepitantdrug

125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.