NCT02440178

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 19, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

November 9, 2021

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

May 3, 2015

Results QC Date

April 1, 2021

Last Update Submit

October 11, 2021

Conditions

Acute Leukemia

Keywords

leukemiainductionprophylaxisantifungalmicafunginphase II

Outcome Measures

Primary Outcomes (1)

  • 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

    the day of 6 weeks after induction chemotherapy

Secondary Outcomes (2)

  • Overall Survival

    the day of 12 weeks after induction chemotherapy

  • Non-relapse Mortality

    The day of 12 weeks after induction chemotherapy

Study Arms (1)

micafungin prophylaxis

EXPERIMENTAL

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

Interventions

MicafunginDRUG
Also known as: mycamine
micafungin prophylaxis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30991992DERIVED

MeSH Terms

Conditions

Leukemia

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Results Point of Contact

Title
Pf. Youngil Koh
Organization
seoul national university
go01@snu.ac.kr
82-2-2072-7217

Study Officials

  • Youngil Koh, Dr.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 12, 2015

Study Start

September 19, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 9, 2021

Results First Posted

November 9, 2021

Record last verified: 2017-10