Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal … (NCT04368559) | Clinical Trial Compass
CompletedPhase 3
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
United States602 participantsStarted 2020-05-11
Plain-language summary
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent.
✓. Males or females ≥18 years of age.
✓. 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.
✓. Diagnosed with 1 of the following underlying diseases:
✓. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
✓. Acute lymphoblastic leukemia, in first or second complete remission.
✓. Acute undifferentiated leukemia in first or second remission.
✓. Acute biphenotypic leukemia in first or second complete remission.
Exclusion criteria
✕. Diagnosis of AML not in morphological remission.
✕. Diagnosis of chemotherapy-resistant lymphoma: a first relapse can occur provided that a second complete remission has occurred.
✕. Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of randomisation.
✕. Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤50%, or shortening fraction ≤26%.
. Personal or family history of Long QT interval on electrocardiogram (ECG) (QT) syndrome or a prolonged QT interval corrected for heart rate by Fridericia's formula (QTcF) (\>470 milliseconds \[msec\] in males and \>480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, quinidine, or halofantrine.
✕. Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin) or forced expiratory volume in 1 second (FEV1) ≤65% of predicted value, or O2 saturation ≤82% on room air.
✕. Suspected or documented PCP within 2 years of screening.
✕. Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (Fungitell ≥80 picograms \[pg\]/mL or Fujifilm Wako \>11 pg/mL) within 15 days prior to the transplant.