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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:3 Months to 20 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Age
• For centers that will use fluconazole as the antifungal comparator:
• Age >= 3 months and < 21 years
• For centers that will use voriconazole as the antifungal comparator:
• Age >= 2 years and < 21 years
• The patient must be undergoing allogeneic HCT from any donor (including matched related) with any stem cell source for any underlying condition
• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use 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/min/1.73 m^2 OR a 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 < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 X upper limit of normal (ULN) for age
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
• Within 90 days of enrollment:
• Patients with a proven or probable invasive mold infection are not eligible
• Patients with an incompletely treated invasive yeast infection are not eligible
• 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 computed tomography [CT] scan) during that time period to be eligible for enrollment
• Patients receiving treatment for an IFI are not eligible
• Patients with a history of echinocandin or azole 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