Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Condition: Fungal Infection; Hematopoietic and Lymphoid Cell Neoplasm
MeSH terms: Infections; Communicable Diseases; Mycoses
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized phase III trial studies how well caspofungin acetate works compared to
      fluconazole or voriconazole in preventing fungal infections in patients following donor stem
      cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in
      preventing fungal infections in patients following donor stem cell transplant. It is not yet
      known whether caspofungin acetate is more effective than fluconazole or voriconazole in
      preventing fungal infections in patients following donor stem cell transplant.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine if caspofungin (caspofungin acetate) is associated with a lower incidence of
      proven/probable invasive fungal infections (IFI) during the first 42 days following
      allogeneic hematopoietic cell transplantation (HCT) at high-risk for IFI compared with azole
      (fluconazole or voriconazole) prophylaxis.

      EXPLORATORY OBJECTIVES:

      I. To determine if caspofungin is associated with a lower incidence of proven/probable IFI
      during the first 100 days following high-risk allogeneic HCT compared with azole (fluconazole
      or voriconazole) prophylaxis. (Exploratory) II. To determine if caspofungin is associated
      with a lower incidence of proven/probable IFI during the first 42 and 100 days following
      high-risk allogeneic HCT compared with fluconazole prophylaxis. (Exploratory) III. To
      determine if caspofungin is associated with a lower incidence of proven/probable IFI during
      the first 42 and 100 days following high-risk allogeneic HCT compared with voriconazole
      prophylaxis. (Exploratory) IV. To determine if caspofungin is associated with a superior
      fungal-free survival (FFS) (time to death or proven/probable IFI) at 42 and 100 days
      following high-risk allogeneic HCT compared with azole prophylaxis. (Exploratory) V. To
      describe the effect that caspofungin and azoles have on the incidence and severity of acute
      graft-versus-host disease (GVHD). (Exploratory) VI. To define the test characteristics of
      weekly Fungitell assay testing for identifying IFI in pediatric hematopoietic stem cell
      transplantation (HSCT) recipients receiving antifungal prophylaxis during the post-transplant
      neutropenic period. (Exploratory) VII. To create a deoxyribonucleic acid (DNA) specimen bank
      in anticipation of the development of biology correlative studies exploring the relationship
      between IFI and single nucleotide polymorphisms (SNPs) of genes involved in immunity.
      (Exploratory)

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive caspofungin acetate intravenously (IV) over 1 hour once daily (QD)
      beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the
      absence of invasive fungal infections or disease progression.

      ARM II: Patients receive fluconazole IV over 1-2 hours QD or orally (PO) QD; or voriconazole
      IV over 1-2 hours QD or PO twice daily (BID) beginning within 24 hours of allogeneic HSCT
      (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or
      disease progression.

      After completion of study treatment, patients are followed up until day 100.
    

Intervention name(s): Caspofungin Acetate; Fluconazole; Laboratory Biomarker Analysis; Voriconazole
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Given IV; Given IV or PO; Optional correlative studies; Given IV or PO
Other intervention name(s): Cancidas; Diflucan; Vfend
Intervention MeSH terms: Fluconazole; Voriconazole; Caspofungin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care