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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Aprepitant
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aprepitant

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Incidence of Vomiting/Retching From 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 Outcome Measures

Presence of Nausea Per Day, on Days 1-8.
Daily Number of Vomiting or Retching Incidents From Days 1-8
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.
Percentage of Participants Experiencing Vomiting or Retching From Days 1-8.
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.
Percentage of Patients Experiencing Nausea From Days 1-8.
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.
To Evaluate the Tolerance of Aprepitant by Documenting All Toxicities on Days 1-8 and All Unexpected Serious Adverse Events up to Day 30.
Severity of Nausea Per Day, on Days 1-8.

Full Information

First Posted
March 25, 2011
Last Updated
November 18, 2021
Sponsor
University Health Network, Toronto
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01334086
Brief Title
Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Official Title
A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aprepitant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Incidence of Vomiting/Retching From Day 1 Through End of Day 5
Description
Cumulative incidence will be determined by the patient self-assessment form, supplemented by the nursing inpatient records.
Time Frame
Day 1 through end of Day 5
Secondary Outcome Measure Information:
Title
Presence of Nausea Per Day, on Days 1-8.
Time Frame
Days 1 to 8
Title
Daily Number of Vomiting or Retching Incidents From Days 1-8
Description
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.
Time Frame
Days 1 to 8
Title
Percentage of Participants Experiencing Vomiting or Retching From Days 1-8.
Description
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.
Time Frame
Days 1 to 8
Title
Percentage of Patients Experiencing Nausea From Days 1-8.
Time Frame
Days 1 to 8
Title
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
Title
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
Title
Severity of Nausea Per Day, on Days 1-8.
Time Frame
Days 1 to 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph M Brandwein, MD, FRCPC
Organizational Affiliation
University Health Network - Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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