Cancer Clinical Trial
Official title:
A Randomized, Comparative Study of Itraconazole Versus Fluconazole for Prevention of Aspergillus Infections in Peripheral Blood Stem Cell and Marrow Transplant Recipients
RATIONALE: Giving itraconazole or fluconazole may be effective in preventing infections in
patients undergoing peripheral stem cell or bone marrow transplantation. It is not yet known
whether itraconazole is more effective than fluconazole for preventing infections.
PURPOSE: Randomized phase III trial to compare the effectiveness of itraconazole with
fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow
transplantation.
OBJECTIVES: I. Compare the efficacy of itraconazole versus fluconazole in reducing the
incidence of breakthrough Aspergillus infections in patients undergoing allogeneic
peripheral blood stem cell or bone marrow transplantation. II. Compare the incidence of
combined mold/yeast infections and the use of alternative systemic antifungal treatments in
these patients on this regimen. III. Compare the toxic effects of these two drugs in these
patients. IV. Determine the survival rate of these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Patients receive fluconazole orally or IV daily beginning at start of conditioning
regimen and continuing until day 180 or until 4 weeks after stopping corticosteroids (if it
occurs between days 120-180). Arm II: Patients receive oral fluconazole daily beginning at
start of conditioning regimen and continuing until day 0. Patients then receive itraconazole
orally or IV daily beginning on day 0 and continuing until day 180, or until 4 weeks after
stopping corticosteroids (if it occurs between days 120-180).
PROJECTED ACCRUAL: A total of 578 patients (289 per arm) will be accrued for this study
within 4 years.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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