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

NCT01334086 | Completed Phase 2 Results DMC

• 1 other identifier: AML-11-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 through end of Day 5

Secondary Outcomes (7)

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

  Days 1 to 8

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

  Days 1 to 8

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

  Days 1 to 8

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

  Days 1 to 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.

  Days 1 to 8

Study Arms (1)

Aprepitant

EXPERIMENTAL

Drug: Aprepitant

Interventions

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.

Also known as: Emend

Aprepitant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Karen Yee, Hematology and Medical Oncology Site Group Lead
• Organization: Princess Margaret Cancer Centre

Karen.Yee@uhn.ca

416-946-4501

Study Officials

• Joseph M Brandwein, MD, FRCPC

  University Health Network - Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: April 12, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 30, 2013
• Last Updated: November 22, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Locations

CA (1)