Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
This study is currently recruiting participants.
Verified January 2013 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Collaborator:
Merck
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01334086
First received: March 25, 2011
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: Aprepitant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase II Open Label Study of Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Cumulative incidence of vomiting/retching from Day 1 through end of Day 5. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Presence of nausea per day, on Days 1-8. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Number of episodes of vomiting or retching per day, on Days 1-8. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Cumulative incidence of vomiting or retching from Days 1-8. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Cumulative incidence of nausea from Days 1-8. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- 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: Up to 1 year ] [ Designated as safety issue: No ]
- 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: Up to 1 year ] [ Designated as safety issue: Yes ]
- Severity of nausea per day, on Days 1-8. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 82 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aprepitant |
Drug: Aprepitant
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 Name: Emend
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334086
Contacts
| Contact: Joseph M Brandwein, MD, FRCPC | 416-946-4501 ext 2824 | joseph.brandwein@uhn.on.ca |
Locations
| Canada, Ontario | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Lorraine Whitehead, RN 416-946-4501 ext 4491 lorraine.whitehead@uhn.ca | |
| Principal Investigator: Joseph M Brandwein, MD, FRCPC | |
Sponsors and Collaborators
University Health Network, Toronto
Merck
Investigators
| Principal Investigator: | Joseph M Brandwein, MD, FRCPC | University Health Network - Princess Margaret Hospital |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01334086 History of Changes |
| Other Study ID Numbers: | AML-11-001 |
| Study First Received: | March 25, 2011 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by University Health Network, Toronto:
|
AML |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Antiemetics Aprepitant |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013