Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)

Inclusion Criteria

• Must receive an allogeneic peripheral blood or marrow transplant from a family or unrelated donor, or for children under the age of 12, a cord blood transplant from either a sibling or other donor
• Must have a 5 or 6 of 6 human leukocyte antigens (HLA)-matched donor. The match may be determined at serologic level for HLA-A and HLA-B loci. For sibling donors, matching may be determined at serologic level for HLA-DR; for unrelated donors, matching for HLA-DRB1 must be at the high-resolution molecular level
• Must have one of the following underlying diseases:
• Acute myelogenous leukemia (AML)
• Acute lymphocytic leukemia (ALL)
• Acute undifferentiated leukemia (AUL)
• Acute biphenotypic leukemia in first or second complete remission
• Chronic myelogenous leukemia (CML) in either chronic or accelerated phase
• One of the following myelodysplastic syndrome(s) (MDS):
• Refractory anemia
• Refractory anemia with ringed sideroblasts
• Refractory cytopenia with multilineage dysplasia
• Refractory cytopenia with multilineage dysplasia and ringed sideroblasts
• Refractory anemia with excess blasts-1 (5-10% blasts)
• Refractory anemia with excess blasts-2 (10-20% blasts)
• MDS, unclassified
• MDS associated with isolated del (5q)
• Chronic myelomonocytic leukemia (CMML)
• Lymphoma (including Hodgkin's) with chemosensitive disease (at least 50% response to chemotherapy) and receiving a related donor transplant
• Receiving myeloablative conditioning regimens
• Adequate physical function (cardiac, hepatic, renal, and pulmonary), within 6 weeks of initiation of conditioning (preferably within 4 weeks) unless otherwise specified
• Baseline galactomannan blood samples drawn within 30 days prior to randomization with the results available prior to randomization (72 hours prior to transplant)
• Chest computed tomography (CT) scans within 6 weeks prior to randomization if the results of the baseline galactomannan blood sample are not available prior to randomization (72 hours prior to transplant)

Exclusion Criteria

• Invasive yeast infection within the 8 weeks prior to conditioning regimen initiation. Patients are eligible if colonized or have had superficial infection. Patients with a history of candidemia greater than 8 weeks prior to conditioning must have a negative blood culture within 14 days of conditioning (within 7 days is recommended), no clinical signs of candidemia, and may not still require antifungal therapy
• Presumptive, proven, or probable aspergillus or other mold infection or deep mycoses (including hepatosplenic candidiasis) within 4 months prior to conditioning regimen initiation
• Uncontrolled viral or bacterial infection at the time of study registration
• Pregnant or breastfeeding. Women of child-bearing age must avoid becoming pregnant while receiving antifungal agents
• Karnofsky performance status less than 70% or Lansky status less than 50% for patients under 16 years old unless approved by the medical monitor or protocol chair
• History of allergy or intolerance to azoles (e.g., fluconazole, itraconazole, voriconazole, posaconazole, ketoconazole, miconazole, clotrimazole)
• Requiring therapy with rifampin, rifabutin, carbamazepine, cisapride (Propulsid®), terfenadine (Seldane®), astemizole (Hismanal®), ergot alkaloids, long-acting barbiturates, or who have received more than 3 days treatment with rifampin or carbamazepine within 7 days prior to conditioning regimen initiation. Patients on therapeutic anticoagulation with coumadin (1 mg/day for port prophylaxis is permitted)
• Receiving sirolimus
• Prolonged QTc syndrome at study entry
• HIV positive
• Receiving another investigational drug unless cleared by the medical monitors
• Received a prior allogeneic or autologous transplant
• Active central nervous system disease
• On fungal prophylaxis during conditioning regimen (it is recommended that fungal prophylaxis be suspended once patient is enrolled)
• Prior cancer, othe