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

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ClinicalTrials.gov Identifier: NCT02440178
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Drug: Micafungin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase II Trial of Micafungin Prophylaxis During Induction Chemotherapy for Patients With Acute Leukemia
Actual Study Start Date : September 19, 2015
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : June 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: micafungin prophylaxis Drug: Micafungin
Other Name: mycamine




Primary Outcome Measures :
  1. the incidence of proven/probable/possible invasive fungal infection [ Time Frame: the day of 6 weeks after induction chemotherapy ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: the day of 12 weeks after induction chemotherapy ]
  2. non-relapse mortality [ Time Frame: the day of 12 weeks after induction chemotherapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440178


Sponsors and Collaborators
Seoul National University Hospital
Astellas Pharma Inc
Investigators
Principal Investigator: Youngil Koh, Dr. Seoul National University Hospital

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02440178     History of Changes
Other Study ID Numbers: SNUH-micafungin
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: October 2017

Keywords provided by Seoul National University Hospital:
leukemia
induction
prophylaxis
antifungal
micafungin
phase II

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents