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

You may be eligible if

• 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:
• 1. Acute myelogenous leukemia (AML)
• 2. Acute lymphocytic leukemia (ALL)
• 3. Acute undifferentiated leukemia (AUL)
• 4. Acute biphenotypic leukemia in first or second complete remission
• 5. Chronic myelogenous leukemia (CML) in either chronic or accelerated phase
• 6. One of the following myelodysplastic syndrome(s) (MDS):
• 1. Refractory anemia
• 2. Refractory anemia with ringed sideroblasts
• 3. Refractory cytopenia with multilineage dysplasia
• 4. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts
• 5. Refractory anemia with excess blasts-1 (5-10% blasts)
• 6. Refractory anemia with excess blasts-2 (10-20% blasts)
• 7. MDS, unclassified
• 8. MDS associated with isolated del (5q)
• 9. Chronic myelomonocytic leukemia (CMML)
• 7. 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)
• 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, other than resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the medical monitor or protocol chair. Cancer previously treated with curative intent over 5 years ago will be allowed