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

October 11, 2021 updated by: Seoul National University Hospital

Phase II Trial of Micafungin Prophylaxis During Induction Chemotherapy for Patients With Acute Leukemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: micafungin prophylaxis
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.
Drug: Micafungin
Other Names:
  • mycamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
Time Frame: the day of 6 weeks after induction chemotherapy
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
the day of 6 weeks after induction chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: the day of 12 weeks after induction chemotherapy
The survival of patients till 12 weeks after induction chemotherapy
the day of 12 weeks after induction chemotherapy
Non-relapse Mortality
Time Frame: The day of 12 weeks after induction chemotherapy
The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression
The day of 12 weeks after induction chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Astellas Pharma Inc

Investigators

  • Principal Investigator: Youngil Koh, Dr., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2015

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

May 3, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (ESTIMATE)

May 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-micafungin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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