Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia

Seoul National University Hospital66 enrolled

Overview

The purpose of this study is to determine whether prophylaxis with micafungin is effective in the induction chemotherapy for newly diagnosed acute leukemia patients.

Medically fit patients with newly diagnosed acute leukemia received 50 mg micafungin intravenously once daily from the initiation of first induction chemotherapy to recovery of neutrophil count, suspected fungal infection, or unacceptable drug-related toxicity.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Acute Leukemia

Interventions

MicafunginDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: A. patients belong to either A-1 or A-2 A-1. patients with newly diagnosed acute myeloid leukemia who approve to get induction chemotherapy with (cytarabine plus idarubicin) or (modified Fludarabine + cytarabine + idarubicin ) A-2. patients with newly diagnosed acute lymphoid leukemia who approve to get induction chemotherapy with VPDL (vincristine + prednisolone + daunorubicin + L-asparaginase), C-VPDL (cyclophosphamide + vincristine + prednisolone + daunorubicin + L-asparaginase), or (R)-hyperCVAD ((Rituximab) + cyclophosphamide + vincristine + Adriamycin + dexamethasone) B. Eastern Cooperative Oncology Group performance status score is equal to or more than 2 C. patients who voluntarily sign the agreement Exclusion Criteria: A. evidence of proven/probable/possible fungal infection within 30 days before induction chemotherapy B. hypersensitivity to echinocandin C. patients had other malignancy within 5 years D. previous treatment history with chemotherapy, radiation therapy, or immunosuppressive therapy. E. pregnant or breast-feeding women F. immunodeficient patients including AIDS G. patients with uncontrolled seizure or psychiatric disorder H. clinically significant heart disorder (myocardial infarction within 3 months or left ventricular ejection fraction \< 40%) I. interstitial lung disease J. previous organ transplantation history K. galactose intolerance L. patients who participated this study before.

Outcomes

Primary Outcomes

Number of Participants With Proven/Probable/Possible Invasive Fungal Infection

proven fungal infection: proven by positive culture for fungus with symptoms and signs of a fungal infection probable fungal infection: direct or indirect detection (galactomannan antigen or serum β-D-glucan) with clinical and radiographic findings possible fungal infection: sufficient clinical evidence for fungal infection was present without mycological evidence

Time frame: the day of 6 weeks after induction chemotherapy

Secondary Outcomes

Overall Survival

The survival of patients till 12 weeks after induction chemotherapy

Time frame: the day of 12 weeks after induction chemotherapy

Non-relapse Mortality

The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression

Time frame: The day of 12 weeks after induction chemotherapy

Data from ClinicalTrials.gov

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