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Study Summary
No. 2008-0615:.......Hematologic Disorder......Jorge Cortes......Leukemia
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Study Summary Title
Study Summary
Number:		2008-0615
Study Title:Phase II, open label, randomized comparative trial of ondansetron alone versus the combination of ondansetron plus aprepitant for the prevention of nausea and vomiting in patients with hematologic malignancies receiving regimens containing high-dose cytarabine
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Physician New Patient Referral
Name:Jorge CortesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5783
Contact us about clinical trials
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General Information
Disease Group:Hematologic DisorderSupported By:Merck
Phase of Study:Phase IIReturn
Visit:		none
Treatment
Agents:		Aprepitant
Ondansetron		Home Care:n/a
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		n/a
Description/
Intervention:		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 AML or
HR-MDS who are receiving cytarabine. The safety of this drug combination will
also be studied.
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Study Objectives / Outcomes
Primary:
To compare the efficacy and safety of ondansetron continuous infusion alone versus ondansetron continuous infusion plus aprepitant in the prevention of nausea and vomiting in patients with acute myelogenous leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS), chronic myelogenous leukemia (CML) in blast crisis or acute undifferentiated leukemia receiving continuous multi-day chemotherapy with a high-dose cytarabine containing regimen.

Secondary:
1. To evaluate the safety of the combination of ondansetron and aprepitant.
2. To compare the frequency and severity of vomiting and nausea between the combination of ondansetron and aprepitant and the ondansetron alone.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:11/11/2009
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients greater than or equal to 18 years of age.

2) Patients with a diagnosis of acute myelogenous leukemia, high-risk myelodysplastic syndrome, chronic myelogenous leukemia in blast crisis or acute undifferentiated leukemia who will receive chemotherapy with regimens containing high-dose cytarabine (greater or equal 1g/m^2/d for at least 3 days).

3) Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Exclusion Criteria:1) Patients with emesis or grade 2 or 3 nausea present less than or equal to 24 hours before chemotherapy.

2) Patients with ongoing emesis due to any organic etiology

3) Patients with known hypersensitivity to the study drug or to 5-HT3 receptor antagonists

4) Patients receiving pimozide, terfenadine, astemizole, or cisapride
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Links
Registration Number: NCT00954941
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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