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

Phase 2

Completed

• Conditions: Acute Leukemia
• Interventions: Drug: Micafungin

• Registration Number: NCT02440178
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Study Start: 2015-09-19
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2017-10
• Results First Submitted: 2021-04-01
• Results First Submitted QC: 2021-10-11
• Last Update Submitted: 2021-10-11
• Results First Posted: 2021-11-09
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
micafungin prophylaxis	Micafungin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection	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

Secondary Outcome Measures

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