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 States, Belgium, Canada602 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 3 trial comparing rezafungin to a standard antifungal regimen for prevention of invasive fungal infections after allogeneic bone marrow transplant — since the trial is now completed, has the data been published, and what did the results show about whether rezafungin worked as well as or better than the standard approach?
2The trial was measuring something called 'fungal-free survival' as its main outcome — can you explain what that means for me, and whether the results suggest rezafungin is a meaningful option for someone in my situation going into a transplant?
3Rezafungin is given as a once-weekly IV infusion — if this drug were to become available or is already available based on these results, how would that dosing schedule compare in terms of convenience and burden to the antifungal prevention regimen you'd normally recommend for me?
4The trial covered a wide range of serious fungal infections including Aspergillus, Candida, and Pneumocystis — based on my specific transplant type and conditioning regimen, which of those infections am I most at risk for, and does that affect whether rezafungin or the standard regimen would be the better fit?
5Since this trial is completed but I'm just now learning about it, is rezafungin FDA-approved or available for antifungal prophylaxis yet, and if not, what is the current standard of care you'd recommend to protect me from invasive fungal disease after my transplant?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.