Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy. This study is determining the incidence of vomiting/retching of the standard induction chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving an antiemetic known as aprepitant.
The standard frontline chemotherapy for patients with AML consists of cytarabine given as a 7 day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days 1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to patients for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3 daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting.
This study will test that the prophylactic use of aprepitant, in addition to the standard antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen, compared to retrospective data using this regimen.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy|
- Cumulative incidence of vomiting/retching from Day 1 through end of Day 5. [ Time Frame: Up to 1 year ]
- Presence of nausea per day, on Days 1-8. [ Time Frame: Up to 1 year ]
- Number of episodes of vomiting or retching per day, on Days 1-8. [ Time Frame: Up to 1 year ]
- Cumulative incidence of vomiting or retching from Days 1-8. [ Time Frame: Up to 1 year ]
- Cumulative incidence of nausea from Days 1-8. [ Time Frame: Up to 1 year ]
- Patients' use of supplemental anti-emetics as determined by the total number of doses per day and in total, from Days 1-8. [ Time Frame: Up to 1 year ]
- To evaluate the tolerance of aprepitant by documenting all toxicities on Days 1-8 and all unexpected serious adverse events up to Day 30. [ Time Frame: Up to 1 year ]
- Severity of nausea per day, on Days 1-8. [ Time Frame: Up to 1 year ]
|Study Start Date:||September 2011|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
Other Name: Emend
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334086
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Joseph M Brandwein, MD, FRCPC||University Health Network - Princess Margaret Hospital|