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

NCT ID: NCT02440178

Last Updated: 2021-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-19

Study Completion Date

2017-06-01

Brief Summary

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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

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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.

Conditions

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Acute Leukemia

Keywords

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leukemia induction prophylaxis antifungal micafungin phase II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Micafungin

Intervention Type DRUG

Interventions

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Micafungin

Intervention Type DRUG

Other Intervention Names

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mycamine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Youngil Koh, Dr.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

References

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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.

Reference Type DERIVED
PMID: 30991992 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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SNUH-micafungin

Identifier Type: -

Identifier Source: org_study_id