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
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Infectious Disease, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/9/2018 |
| Start Date: | September 9, 2010 |
| End Date: | April 3, 2018 |
A Randomized Open-Label Trial of 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
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. When people take chemotherapy, they are more likely to get
infections. Posaconazole has been approved for the prevention of fungal infections in
patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.
Posaconazole is available only as an oral suspension and has to be given with food. After
chemotherapy, many patients are not able to tolerate food or oral medication because of
severe mucositis. Patients unable to tolerate food and oral medications cannot take
posaconazole.
Micafungin is an antifungal medication that is given only intravenously. Micafungin is
approved for the treatment of certain fungal infections and for preventing fungal infections
in patients who receive bone marrow transplant. The investigators know that micafungin is
safe. Micafungin has not been tested for the prevention of fungal infections in patients
receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is
given by vein, it can be given even in patients who cannot take food or medications by mouth
after chemotherapy. In this study the investigators want to compare micafungin to
posaconazole when given for the prevention of fungal infections in leukemia and
myelodysplastic syndrome patients.
micafungin in preventing fungal infections after chemotherapy for acute leukemia or
myelodysplastic syndrome. When people take chemotherapy, they are more likely to get
infections. Posaconazole has been approved for the prevention of fungal infections in
patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.
Posaconazole is available only as an oral suspension and has to be given with food. After
chemotherapy, many patients are not able to tolerate food or oral medication because of
severe mucositis. Patients unable to tolerate food and oral medications cannot take
posaconazole.
Micafungin is an antifungal medication that is given only intravenously. Micafungin is
approved for the treatment of certain fungal infections and for preventing fungal infections
in patients who receive bone marrow transplant. The investigators know that micafungin is
safe. Micafungin has not been tested for the prevention of fungal infections in patients
receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is
given by vein, it can be given even in patients who cannot take food or medications by mouth
after chemotherapy. In this study the investigators want to compare micafungin to
posaconazole when given for the prevention of fungal infections in leukemia and
myelodysplastic syndrome patients.
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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Genovefa Papanicolaou, MD
Phone: 212-639-8361
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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