A Study of Posaconazole Versus Micafungin to Protect Against Invasive Fungal Infections in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Protocol
10-038
Full Title
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
Phase
IV
Purpose

When people receive chemotherapy, they are more likely to get infections, including fungal infections, due to low white blood cell counts. Posaconazole has been approved to prevent fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. It is a liquid medicine that is taken by mouth, with food. But some people who receive chemotherapy develop an irritation of the mouth called mucositis, and are unable to taken posaconazole because they cannot tolerate food or oral medicines.

Micafungin is an antifungal medication that is given intravenously. It is approved for treating certain fungal infections and for preventing fungal infections in patients who receive a bone marrow transplant. In this study, researchers want to compare micafungin and posaconazole for the prevention of fungal infections in leukemia and myelodysplastic syndrome patients undergoing chemotherapy. Patients will be randomly assigned to receive one drug or the other.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be planning to have induction of re-induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome and be at risk of low white blood cell counts during treatment.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.

Disease(s)
Hematology: Myelodysplastic Syndrome
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Leukemia: Acute Myelogenous Leukemia
Leukemia: Myelodysplastic Syndrome
Locations

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