Acute Myeloid LeukemiaPhase 2NCT01334086
Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
A Phase 2 study testing Aprepitant in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to 30 Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open Label Study of 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Aprepitant
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
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.
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Experimental | Not described Receives: Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 through end of Day 5
Secondary outcomes (7)
Presence of Nausea Per Day, on Days 1-8.
Measured: Days 1 to 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.
Measured: Days 1 to 8
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.
Measured: Days 1 to 8
Percentage of Patients Experiencing Nausea From Days 1-8.
Measured: 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.
Measured: Days 1 to 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.
Measured: Days 1 to 8
Severity of Nausea Per Day, on Days 1-8.
Measured: Days 1 to 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completion30 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Joseph M Brandwein, MD, FRCPC, Principal investigator, University Health Network - Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334086
- Sponsor's protocol ID
- AML-11-001
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2011
- Last updated
- 22 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT01334086
- Acronym / sponsor ID
- AML-11-001
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- 30 Aug 2013 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aprepitant | Experimental | Drug: Aprepitant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AprepitantAlso: EmendOral 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. | Drug | Aprepitant |
Primary outcome
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.
7 secondary outcomes
Presence of Nausea Per Day, on Days 1-8.
Time frame: Days 1 to 8
Daily Number of Vomiting or Retching Incidents From Days 1-8
Time frame: Days 1 to 8
Percentage of Participants Experiencing Vomiting or Retching From Days 1-8.
Time frame: Days 1 to 8
Percentage of Patients Experiencing Nausea From Days 1-8.
Time frame: 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.
Time frame: Days 1 to 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.
Time frame: Days 1 to 8
Severity of Nausea Per Day, on Days 1-8.
Time frame: Days 1 to 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Brandwein, MD, FRCPC principal investigator
University Health Network - Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aprepitant in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.