Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Collaborator: University of Georgia
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Emetics; Fosaprepitant; Olanzapine; Ondansetron

Criteria

Inclusion Criteria:

• Inpatient or outpatient hematology patient receiving one of the following regimens:

• Chemotherapy for hematologic malignancy:

• ABVD

• ICE ± R

• 7+3

• Conditioning therapy for stem cell transplantation:

• BEAM

• Bu/Cy ± ATG

• Bu/Flu ± ATG

• FluCy ± ATG

• FluCy + TBI

• BuMel

• FluBuCy

• Melphalan

• Etoposide + TBI

• Cyclophosphamide + TBI

Exclusion Criteria:

• Allergy to olanzapine

• Documented nausea or vomiting ≤24 hours prior to enrollment

• Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol therapy

• Chronic alcoholism

• Pregnant

• Declined or unable to provide an informed consent