Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups

EORTC-65091-06093

RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan. PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

2012-03-01

2019-04-04

2019-04-04

Completed

Early phase I

556

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) * Newly diagnosed disease or disease in first relapse after hematological remission lasting for a minimum of 6 months AND meets one of the following criteria: * Starting remission-induction chemotherapy within 3 days prior to study randomization * Starting myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic stem cell transplantation within 3 days prior to study randomization * Planning a hospital admission for the duration of the neutropenic phase (ANC \< 0.5 x 10\^9 /L) * Planning to receive oral or intravenous fluconazole for Candida prophylaxis at a dose of 400 mg/day * Fluconazole is discontinued during caspofungin acetate administration * No previous or current history of proven or probable invasive fungal disease (IFD) PATIENT CHARACTERISTICS: * See Disease Characteristics * Not pregnant or nursing * Negative pregnancy test * Fertile patients muse use effective contraception during and for at least 3 months after completion of study therapy * No current clinical diagnosis of pneumonia * No serious, uncontrolled, concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol * No history of allergy or any adverse reaction to echinocandin drugs (i.e., caspofungin acetate, micafungin, or anidulafungin) * No hypersensitivity to caspofungin active substance or to any of the excipients * No inadequately treated infection * No documented HIV infection * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * No history of liver cirrhosis or severe hepatic insufficiency (i.e., Child Pugh Class C, D, or E) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent participation on another clinical trial using an investigational drug for infectious diseases * No other concurrent systemic antifungal therapy (oral or intravenous)

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2023-12-11