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A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Cumulative incidence of vomiting/retching from Day 1 through end of Day 5.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Joseph M Brandwein, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network - Princess Margaret Hospital

Authority:

Canada: Health Canada

Study ID:

AML-11-001

NCT ID:

NCT01334086

Start Date:

September 2011

Completion Date:

June 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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