Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Aprepitant
Intervention description: 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.
Intervention MeSH terms: Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AML

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.
    

Eligibility criteria:

        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.