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Phase 2 Completed N=66 Prevention

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

Source: ClinicalTrials.gov NCT02440178 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants With Proven/Probable/Possible Invasive Fungal Infection — 1; 0; 2; 62 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
1; 0; 2; 62
SECONDARY
Overall Survival
62; 3
SECONDARY
Non-relapse Mortality
3; 62

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02440178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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