ReSPECT

A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

Study treatments

• Arm 1: Rezafungin for Injection 
• Arm 2: Oral Antifungal 

Inclusion criteria

• 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:

  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 specified myelodysplastic syndrome(s) 
• Receiving myeloablative or reduced-intensity conditioning regimens.

Exclusion criteria

• Diagnosis of AML not in morphological remission.
• Diagnosis of chemotherapy-resistant lymphoma.
• Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of screening.
• Receipt of previous allogeneic BMT.
• Planned receipt of cord blood for transplantation.
• Planned peripheral blood or marrow autograft.
• Underlying diagnosis of multiple myeloma.

Participating sites

• University Hospital Leuven Gasthuisberg