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Clinical Trial COGACCL1131

Title

A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFi Following Allogeneic Hematopoietic Cell Transplantation (HCT)

Principal Investigator(s)

Adam Esbenshade

Details

  • Protocol No. COGACCL1131
  • Open Date: 06/12/2013
  • Staging: Phase III
  • Age Group: Both Child and Adult
  • Scope: International
  • Objective: To determine if Caspofungin is associated with a lower incidence of proven/probable IFI during the first 42 days following allogeneic HCT at high-risk for IFI compared with azole (fluconazole or voriconazole) prophylaxis
  • Disease Sites: Pediatrics
  • Therapies: Therapy (NOS)
  • Drugs: Caspofungin; Fluconazole
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01503515
  • Secondary Protocol No: ACCL1131

Description

None Provided.

Eligibility

Ages Eligible for Study:N/A to 20 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• The patient must be undergoing allogeneic hematopoietic cell transplantation (HCT) for treatment of a malignancy, bone marrow failure syndrome, or congenital immunodeficiency
• The source for allogeneic stem cells (bone marrow, peripheral blood stem cells [PBSC], or umbilical cord blood) must be an unrelated donor or mismatched (≤ 7/8 at human leukocyte antigen [HLA]-A, B, C, and DR if bone marrow or PBSC; ≤ 5/6 at HLA-A, B, and DR if cord blood) family donor
• Patients with an elevated galactomannan level (≥ 0.5 Index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest CT scan) during that time period to be eligible for enrollment
• Age ≥ 3 months and < 21 years for patients receiving fluconazole as antifungal comparator
• Age ≥ 2 years and < 21 years for patients receiving voriconazole as the antifungal comparator
• ECOG scores of 0, 1 or 2 (Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age)
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL OR serum creatinine based on age/gender as follows:
• 0.4 mg/dL (1 month to < 6 months of age)
• 0.5 mg/dL (6 months to < 1 year of age)
• 0.6 mg/dL (1 to < 2 years of age)
• 0.8 mg/dL (2 to < 6 years of age)
• 1.0 mg/dL (6 to < 10 years of age)
• 1.2 mg/dL (10 to < 13 years of age)
• 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
• 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age (unless the increase in bilirubin is attributable to Gilbert syndrome)
• SGOT (AST) or SGPT (ALT) < 2.5 times ULN for age
• Patients with a history of proven or probable invasive mold infection are not eligible
• Patients with an incompletely treated invasive yeast infection are not eligible
• Patients with a history of anidulafungin (echinocandin) or azole (fluconazole or voriconazole) hypersensitivity are not eligible
• Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
• Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
• Lactating females are not eligible unless they have agreed not to breastfeed their infants
• Patients receiving treatment for an invasive fungal infection (IFI) are not eligible