Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334086
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : June 22, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Aprepitant Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : August 2013

Arm Intervention/treatment
Experimental: Aprepitant Drug: Aprepitant
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

Primary Outcome Measures :
  1. Cumulative incidence of vomiting/retching from Day 1 through end of Day 5. [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Presence of nausea per day, on Days 1-8. [ Time Frame: Up to 1 year ]
  2. Number of episodes of vomiting or retching per day, on Days 1-8. [ Time Frame: Up to 1 year ]
  3. Cumulative incidence of vomiting or retching from Days 1-8. [ Time Frame: Up to 1 year ]
  4. Cumulative incidence of nausea from Days 1-8. [ Time Frame: Up to 1 year ]
  5. 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 ]
  6. 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 ]
  7. Severity of nausea per day, on Days 1-8. [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute myeloid leukemia (AML), any subtype including acute promyelocytic leukemia (APL). Patients with either de novo or secondary AML are eligible.
  • No prior AML induction chemotherapy.
  • Due to receive standard 3+7 induction chemotherapy using daunorubicin on Days 1-3, plus cytarabine continuous infusion daily on Days 1-7.
  • Age 18 and over.
  • Serum bilirubin < or = 1.5 times the upper limit of normal (ULN).
  • Serum aspartate aminotransferase and alanine aminotransferase < or = 2.5 times the ULN.
  • Serum creatinine < 200 umol/L

Exclusion Criteria:

  • Uncontrolled nausea or vomiting within 48 hours prior to start of induction therapy. Grade 0-1 nausea is permitted at the start of induction.
  • Known hypersensitivity to granisetron or aprepitant.
  • Patients currently receiving treatment with strong CYP3A4 inhibitors or substrates and treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
  • Not able to swallow or absorb oral medications.
  • Documented active central nervous system (CNS) leukemia or recent CNS hemorrhage.
  • Concomitant use of:

    1. Other investigational agents during induction therapy
    2. Radiotherapy during, or one month prior to, induction therapy
    3. Systemic corticosteroids
    4. Other chemotherapy agents on Days 1-8
  • Pregnant or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334086

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Merck Sharp & Dohme Corp.
Principal Investigator: Joseph M Brandwein, MD, FRCPC University Health Network - Princess Margaret Hospital

Responsible Party: University Health Network, Toronto Identifier: NCT01334086     History of Changes
Other Study ID Numbers: AML-11-001
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action