Lymphoma Clinical Trial
Official title:
A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS
RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in
patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal
nystatin is more effective than standard amphotericin B in treating patients with fever and
neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow
transplantation for leukemia.
PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin
compared with standard amphotericin B to treat fever and neutropenia in patients receiving
chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.
OBJECTIVES: I. Compare the efficacy of liposomal nystatin vs standard amphotericin B for the
empiric treatment of persistent febrile neutropenic patients. II. Compare the incidence of
drug-related toxicity or impairment and infusion-related toxicity in patients treated with
liposomal nystatin vs standard amphotericin B. III. Determine the pharmacokinetics of
liposomal nystatin.
OUTLINE: Randomized, double-blind study. Arm I: Antifungal Therapy. Liposomal Nystatin. Arm
II: Antifungal Therapy. Amphotericin B, NSC-527017.
PROJECTED ACCRUAL: 350 evaluable patients will be studied in this multicenter trial.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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