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NCT Number: NCT01334086

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

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 names: Emend

Primary outcomes

  1. Percentage of Participants With Incidence of Vomiting/Retching From Day 1 Through End of Day 5

    Time frame: Day 1 through end of Day 5

    Cumulative incidence will be determined by the patient self-assessment form, supplemented by the nursing inpatient records.

Secondary outcomes

  1. Presence of Nausea Per Day, on Days 1-8.

    Time frame: Days 1 to 8

  2. Daily Number of Vomiting or Retching Incidents From Days 1-8

    Time frame: Days 1 to 8

    This will be determined by both self-assessment form which will be filled out by the patient on a daily basis, and review of the nursing inpatient records.

  3. Percentage of Participants Experiencing Vomiting or Retching From Days 1-8.

    Time frame: Days 1 to 8

    This will be determined by both self-assessment form which will be filled out by the patient on a daily basis, and review of the nursing inpatient records.

  4. Percentage of Patients Experiencing Nausea From Days 1-8.

    Time frame: Days 1 to 8

  5. Percentage of 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: Days 1 to 8

  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: Days 1 to 8

  7. Severity of Nausea Per Day, on Days 1-8.

    Time frame: Days 1 to 8

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 12, 2011
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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