Status:
COMPLETED
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. ...
Eligibility Criteria
Inclusion
- Subjects of greater than or equal to 18 years of age of either sex and of any race.
- Disease definition:
- Anticipated or documented prolonged neutropenia (ANC\<500/mm3 \[0.5x109/L\]) at baseline or likely to develop within 3 to 5 days and lasting for at least 7 days due to:
- Intensive induction chemotherapy for new diagnosis of acute myelogenous leukemia, acute lymphocytic leukemia or myelodysplastic syndrome receiving standard anthracycline based chemotherapy
- Re-induction of acute myelogenous or lymphocytic leukemia after primary relapse
- Myelodysplastic syndromes requiring induction (myelosuppressive) chemotherapy
- Female subjects of childbearing potential must have a negative serum pregnancy test as per MSKCC guidelines.
- Able to swallow oral medications
Exclusion
- Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization.
- Subjects who are taking the following:
- Drugs known to interact with posaconazole and that may lead to life-threatening side effects (terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry); b. Drugs known to lower the serum concentration/efficacy of posaconazole: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry; c. Subjects who are planned to receive \> 2mg flat dose of vinca alkaloids.
- Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
- Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at baseline or likely to require dialysis during the study).
- Subjects having an electrocardiogram with a prolonged QTc interval by manual reading: QTc greater than 490 msec.
- Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN.
- Subjects who are undergoing re-induction chemotherapy and have participated in this study during their first induction chemotherapy.
- Subjects who will be receiving dasatinib.
Key Trial Info
Start Date :
September 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01200355
Start Date
September 9 2010
End Date
April 3 2018
Last Update
May 7 2018
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065