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
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring MICAFUNGIN, POSACONAZOLE, antifungal, prolonged neutropenia, 10-038
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
micafungin
posaconazole
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).