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
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI CTRP
interventional
100
1 country
1
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2009
Actual (reported)August 7, 2009
Actual (reported)November 2009
Date type not reportedThis date has not been verified as actual or estimated.
April 2013
Actual (reported)January 13, 2014
Actual (reported)May 2015
Actual (reported)Participant Responses
Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.
First 6 treatment days
Treatment Success Rate
Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.
First 6 treatment days
Ondansetron 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.
Ondansetron 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. Aprepitant 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.
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.
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Jorge Cortes, MD
M.D. Anderson Cancer Center
100 participants (actual enrollment reported by the registry).
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2013
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
June 25, 2015
Results First Posted
January 13, 2014
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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