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

Acute Leukemia Clinical Trial

Official title:

Phase II Trial of Micafungin Prophylaxis During Induction Chemotherapy for Patients With Acute Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440178
• Other study ID #: SNUH-micafungin
• Status: Completed
• Phase: Phase 2
• Start date: September 19, 2015
• Est. completion date: June 1, 2017

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Drug:
• Micafungin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Astellas Pharma Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ß-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	Overall Survival	The survival of patients till 12 weeks after induction chemotherapy	the day of 12 weeks after induction chemotherapy
Secondary	Non-relapse Mortality	The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression	The day of 12 weeks after induction chemotherapy