Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

Inclusion Criteria

• •1. Willing and able to provide written informed consent.
• •2. Males or females ≥18 years of age.
• •3. Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
• •4. Diagnosed with 1 of the following underlying diseases:
• •1. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
• •2. Acute lymphoblastic leukemia, in first or second complete remission.
• •3. Acute undifferentiated leukemia in first or second remission.
• •4. Acute biphenotypic leukemia in first or second complete remission.
• •5. Chronic myelogenous leukemia in either chronic or accelerated phase.
• •6. One of the following myelodysplastic syndrome(s) defined by the following:
• •i. Refractory anemia.
• •ii. Refractory anemia with ringed sideroblasts.
• •iii. Refractory cytopenia with multilineage dysplasia.
• •iv. Refractory cytopenia with multilineage dysplasia and ringed sideroblasts.
• •v. Refractory anemia with excess blasts - 1 (5-10% blasts).
• •vi. Refractory anemia with excess blasts - 2 (10-20% blasts).
• •vii. Myelodysplastic syndrome, unclassified.
• •viii. Myelodysplastic syndrome associated with isolated del (5q).
• •g. Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related or unrelated donor transplant.
• •h. Aplastic anemia.
• •i. Primary or secondary myelofibrosis.
• •j. Chronic myelomonocytic leukemia.
• •k. Chronic lymphocytic leukemia.
• •l. Drepanocytosis (sickle cell anemia).
• •m. Red blood cell aplasia.
• •n. Myeloproliferative disorder, unclassified.
• •o. Multiple myeloma (plasma cell myeloma).
• •5. Receiving myeloablative or reduced-intensity conditioning regimens.
• •6. Adequate renal and hepatic function prior to initiation of conditioning regimen, therefore between 40 days prior and 10 days prior to BMT, documented as follows:
• •1. Hepatic: alanine aminotransferase less than or equal to (≤) 2.5 × upper limit of normal (ULN) and total serum bilirubin ≤1.5 × ULN (excluding Gilbert's Syndrome).
• •2. Renal: serum creatinine ≤2 milligrams (mg)/deciliter (dL) and with creatinine clearance (CrCl) greater than or equal to (≥) 30 milliliters (mL)/minute (min) without a history of renal transplant, or undergoing weekly dialysis within 4 weeks of the BMT.
• •7. Baseline blood samples drawn for Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 15 days before randomization, with results available prior to randomization.
• •8. Baseline Toxoplasma serologies available within 6 weeks prior to randomization. Subjects with a positive toxoplasma IgG serology at any time prior to randomization do not need to repeat the toxoplasma serologies (IgG and IgM) and will be considered to have a prior history of toxoplasmosis.
• •9. Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency determination by the investigator prior to randomization with no known evidence of G6PD deficiency performed any time prior to randomization. If the Investigator assesses the subject as G6PD sufficient, the G6PD test result does not need to be entered into the EDC system.
• •10. Female subjects of child-bearing potential \<2 years post-menopausal (unless surgically sterile) must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subject's usual lifestyle) while participating in this study, and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug.