Acute Leukemia
Conditions
Keywords
leukemia, induction, prophylaxis, antifungal, micafungin, phase II
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.
Interventions
DRUGMicafungin
Sponsors
Astellas Pharma Inc
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micafungin Prophylaxis The baseline characteristics of total patients | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Micafungin Prophylaxis |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants |
| Age, Continuous | 51 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 65 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Korea | 65 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 65 |
| other Total, other adverse events | 3 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
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 β-D-glucan) with clinical and radiographic findings possible fungal infection: sufficient clinical evidence for fungal infection was present without mycological evidence
Time frame: the day of 6 weeks after induction chemotherapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Micafungin Prophylaxis | Number of Participants With Proven/Probable/Possible Invasive Fungal Infection | Probable fungal infection | 0 Participants |
| Micafungin Prophylaxis | Number of Participants With Proven/Probable/Possible Invasive Fungal Infection | Proven fungal infection | 1 Participants |
| Micafungin Prophylaxis | Number of Participants With Proven/Probable/Possible Invasive Fungal Infection | Possible fungal infection | 2 Participants |
| Micafungin Prophylaxis | Number of Participants With Proven/Probable/Possible Invasive Fungal Infection | Non fungal infection | 62 Participants |
Secondary
Non-relapse Mortality
The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression
Time frame: The day of 12 weeks after induction chemotherapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Micafungin Prophylaxis | Non-relapse Mortality | survival | 62 Participants |
| Micafungin Prophylaxis | Non-relapse Mortality | Non-relapse mortality | 3 Participants |
Secondary
Overall Survival
The survival of patients till 12 weeks after induction chemotherapy
Time frame: the day of 12 weeks after induction chemotherapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Micafungin Prophylaxis | Overall Survival | survival | 62 Participants |
| Micafungin Prophylaxis | Overall Survival | death | 3 Participants |