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

Primary Purpose

Acute Leukemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Micafungin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Leukemia focused on measuring leukemia, induction, prophylaxis, antifungal, micafungin, phase II

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    micafungin prophylaxis

    Arm Description

    Patients received 50 mg micafungin intravenously once daily from the initiation of induction chemotherapy to recovery of neutrophil count (absolute neutrophil count > 500/μg for three consecutive days), suspected fungal infection, or occurrence of drug-related toxicity.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Overall Survival
    The survival of patients till 12 weeks after induction chemotherapy
    Non-relapse Mortality
    The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression

    Full Information

    First Posted
    May 3, 2015
    Last Updated
    October 11, 2021
    Sponsor
    Seoul National University Hospital
    Collaborators
    Astellas Pharma Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02440178
    Brief Title
    Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia
    Official Title
    Phase II Trial of Micafungin Prophylaxis During Induction Chemotherapy for Patients With Acute Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 19, 2015 (Actual)
    Primary Completion Date
    June 1, 2017 (Actual)
    Study Completion Date
    June 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital
    Collaborators
    Astellas Pharma Inc

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Leukemia
    Keywords
    leukemia, induction, prophylaxis, antifungal, micafungin, phase II

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    micafungin prophylaxis
    Arm Type
    Experimental
    Arm Description
    Patients received 50 mg micafungin intravenously once daily from the initiation of induction chemotherapy to recovery of neutrophil count (absolute neutrophil count > 500/μg for three consecutive days), suspected fungal infection, or occurrence of drug-related toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    Micafungin
    Other Intervention Name(s)
    mycamine
    Primary Outcome Measure Information:
    Title
    Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
    Description
    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 Outcome Measure Information:
    Title
    Overall Survival
    Description
    The survival of patients till 12 weeks after induction chemotherapy
    Time Frame
    the day of 12 weeks after induction chemotherapy
    Title
    Non-relapse Mortality
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Youngil Koh, Dr.
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30991992
    Citation
    Park H, Youk J, Shin DY, Hong J, Kim I, Kim NJ, Lee JO, Bang SM, Yoon SS, Park WB, Koh Y. Micafungin prophylaxis for acute leukemia patients undergoing induction chemotherapy. BMC Cancer. 2019 Apr 16;19(1):358. doi: 10.1186/s12885-019-5557-9.
    Results Reference
    derived

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

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