Clinical trial NCT02440178: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Leukemia
Keywords: leukemia
induction
prophylaxis
antifungal
micafungin
phase II
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2015-05-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
timeFrame: the day of 6 weeks after induction chemotherapy
Secondary outcomes:
measure: Overall Survival
timeFrame: the day of 12 weeks after induction chemotherapy
measure: Non-relapse Mortality
timeFrame: The day of 12 weeks after induction chemotherapy
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Youngil Koh, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.