A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
- 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
- Serum creatinine < 200 umol/L
- 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.