A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days

Inclusion Criteria:

• Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:

  • Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
  • Any patient undergoing an allogeneic hematopoietic stem cell transplant

Exclusion Criteria:

• Patients with moderate or severe liver disease, as defined by:

  • AST or ALT greater than 5 times upper limit of normal (ULN), OR;
  • Total bilirubin greater than 2.5 times ULN

• Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment